In What Ways Can Technology Be Used to Collect and Analyze Cardiovascular Data

• Study protocol
• Open Access
• Published: 21 November 2019

Harnessing technology and molecular assay to understand the evolution of cardiovascular diseases in Asia: a prospective accomplice study (SingHEART)

• Weng Khong Lim^2,iii,
• Anders Sahlénⁱ,
• Calvin Woon-Loong Chin¹,
• Kenneth Michael Yun-Chi Chew ORCID: orcid.org/0000-0001-9961-1255 ^one,
• Sonia Davila^2,4,
• John Allen¹,
• Vera Goh¹,
• Swee Yaw Tan¹,
• Patrick Tan^2,iii,
• Carolyn S. P. Lam^1,4,
• Stuart Alexander Cook^i,2 &
• Khung Keong Yeo^one,v

BMC Cardiovascular Disorders volume 19, Article number:259 (2019) Cite this article

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Abstract

Groundwork

Cardiovascular illness (CVD) imposes much mortality and morbidity worldwide. The employ of "deep learning", advancements in genomics, metabolomics, proteomics and devices like wearables have the potential to unearth new insights in the field of cardiology. Currently, in Asia, there are no studies that combine the use of conventional clinical information with these avant-garde technologies. Nosotros aim to harness these new technologies to understand the development of cardiovascular disease in Asia.

Methods

Singapore is a multi-ethnic state in Asia with well-represented diverse ethnicities including Chinese, Malays and Indians. The SingHEART study is the outset technology driven multi-ethnic prospective population-based study of healthy Asians. Salubrious male and female subjects aged 21–69 years old without any prior cardiovascular illness or diabetes mellitus will be recruited from the general population. All subjects are consented to undergo a detailed on-line questionnaire, basic blood investigations, resting and continuous electrocardiogram and claret pressure monitoring, activity and slumber tracking, calcium score, cardiac magnetic resonance imaging, whole genome sequencing and lipidomic analysis. Outcomes studied volition include mortality and cause of bloodshed, myocardial infarction, stroke, malignancy, heart failure, and the development of co-morbidities.

Discussion

An initial target of 2500 patients has been set. From October 2015 to May 2017, an initial 683 subjects have been recruited and take completed the initial work-up the SingHEART projection is the start contemporary population-based study in Asia that will include whole genome sequencing and deep phenotyping: including advanced imaging and article of clothing data, to better understand the development of cardiovascular disease beyond dissimilar indigenous groups in Asia.

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Background

Cardiovascular disease (CVD) is a major cause of mortality and morbidity worldwide. Traditional big population-based studies in Western cohorts (e.g. Framingham Centre Written report, Cardiovascular Wellness Study, Atherosclerosis Risk in Communities Study, Jackson Heart cohort) have formed the foundation of our initial cognition on the take a chance factors of cardiovascular disease [1,two,iii,4]. With advancements in technology, there have been many more than heady developments in our understanding of the development and prevention of CVD. Advances fabricated in genomics, metabolomics, proteomics and data from wearables have the potential to evangelize important new insights in the field of cardiology, especially later smaller datasets are combined into multi-domain, high-dimensionality "big information" and analyzed using novel machine learning techniques.

In the last couple of years, the American Centre Association (AHA) and Google Life Sciences (GLS) have forged a joint collaboration to employ engineering to tackle the scourge of CVD [5]. This collaboration will permit the scientific customs to leverage on the technical capabilities and insights offered by Google Life Sciences. With the unique opportunity to access such resource, this project is forecasted to permit researchers to conceptualize and examination new approaches [v]. Contempo modern prospective population-based studies (Projection Baseline, MURDOCK study) take likewise been developed to answer these questions with the aid of technology [six, 7]. Projection Baseline aims to narrate participants across clinical, molecular, imaging, sensor, self-reported, behavioural, psychological, environmental and other health-related measurements from onsite visits, continuous data collection through sensor engineering science, and regular engagement via an online portal and mobile app [6]. The MURDOCK study aims to reclassify cardiovascular take a chance using integrated clinical and molecular biosignatures. Notwithstanding, these studies are based primarily in Western populations [7].

Ethnic differences in CVD exist [viii,ix,ten,11]. The Multi-Ethnic Written report of Atherosclerosis (MESA) study institute distinct racial differences in the adventure of incident eye failure [eight]. The mechanisms are multifactorial with complex interactions between unmodifiable genetic factors and acquired risk factors. Often times, it has been hard to distinguish the contributory office betwixt socioeconomic and genetic factors towards evolution of disease with residual uncertainty regarding causality and pathogenic mechanisms [12, 13]. Currently, in Asia, there are no population-based studies that combine the use of conventional clinical information with avant-garde 'discovery'-type molecular techniques, advanced quantitative cardiac imaging and article of clothing technologies to narrate the general customs. We aim to harness these new technologies to understand the development of cardiovascular disease in Asia.

Methods

Study design and population

Singapore is a developed metropolis state of v.6 million people in Asia with well-represented various ethnicities including Chinese (74.3%), Malays (13.four%) and Indians (nine.1%). The elderly ≥65 yr account for 12.4% of the population and the boilerplate life-expectancy is 82.9 years old [xiv].

The SingHEART study is the start multi-ethnic prospective population-based report of healthy Asians harnessing the latest technologies. In summary, healthy male and female subjects aged 21–69 years old without any prior cardiovascular disease (Ischemic heart disease, stroke, peripheral vascular affliction) or diabetes mellitus volition be recruited from the full general population. The complete inclusion and exclusion criteria are found in the supplementary appendix (Additional file i: Appendix 1). These patients are fatigued from a accomplice of healthy individuals who have already volunteered to the institutional Biobank program. Subjects fulfilling the inclusion criteria will be recruited from the public via advertisements (e.g. posters, local newspaper).

Written informed consent will exist obtained from every subject and includes follow-up of upwardly to 20 years, including agreement to permit tracking of outcomes via national and disease registries. Subjects will be informed of incidental abnormalities picked up during the tests. If genetic abnormalities are detected, in that location is an choice for genetic counselling. All data will be anonymized for analysis.

Ethical blessing was obtained from the Singhealth institutional review lath.

Objectives

This written report aims to comprehensively characterize a salubrious Asian population at baseline and at follow-up, using multiple modalities to aid in the understanding of the traditional and novel factors that contribute to the development of cardiovascular disease. Emphasis will be placed on understanding how these traditional and novel factors collaborate, besides every bit on elucidating the ethnic differences in the development of cardiovascular disease. The specific objectives are as follows:

• To characterize cardiovascular health in Asia by measuring multiple systems simultaneously and longitudinally.

• To assess lifestyle, diet, physical activeness and sleep via traditional questionnaire surveys and wearable technologies and their impact on the development of cardiovascular disease.

• To narrate baseline genetic, metabolic and advanced cardiac imaging profiles in healthy individuals and the identification of novel markers influencing the evolution of cardiovascular disease with the potential for therapeutics.

• Validate patient-reported sleep/physical activity and that derived by wearables, study the impact of concrete activity on cardiac structure, investigate relationship betwixt calcium score and lifestyle factors, etc.

• To study the development and progression of cardiovascular illness in these patients to help develop new preventive, diagnostic and predictive tools for the Asian population

• To empathise the differential effects of ethnicity on the development of cardiovascular disease

• To utilize both traditional statistical assay and newer methodologies (due east.k. car learning) to process and clarify the data

Report protocol

Each subject volition undergo the following investigations at baseline and at specific intervals on follow-upwardly for upwardly to xx years, as described in Table 1.

Table 1 List and timeline of investigations for SingHEART

Full size table

Questionnaire

The questionnaire will include sections on demographics, socioeconomic status, medical history, lifestyle, diet and exercise, quality of life as assessed by the EQ-5D-3 Fifty, Pittsburgh slumber quality index and International Alphabetize of Erectile Function (IIEF)- 5 (just for males). See supplementary appendix for the complete questionnaire (Boosted file two: Appendix 2).

Basic claret investigations

This will include total blood count, renal and liver role, fasting lipids and fasting glucose. As diabetes mellitus is an exclusion criterion, HbA1c volition not be measured routinely. Samples are biobanked for time to come use through the NHCS biobank.

Electrocardiogram

A standard 12-atomic number 82 resting ECG will be recorded. Variables studied volition include charge per unit, rhythm, axis, conduction intervals, morphologies (including QRS, S-T and T wave abnormalities) and arrhythmias.

Convalescent BP monitor

Ambulatory blood pressure monitoring will be performed for 24 h via a cuff-monitoring (Spacelab Healthcare Model 90,227/90217A). Information collected will include the systolic, diastolic and hateful blood pressure during the day and night, as well as data on dipping.

Continuous ECG monitoring

Continuous ECG monitoring will be performed for 24 h–72 h via a wearable, multi-pb ECG monitoring patch which stores data for up to 3 days (ePatch® ECG recorder AMS3000). Information nerveless will include variations in heart rate and the diverse types of arrhythmias present.

Action and slumber tracker

A commercially bachelor wearable fitness device able to runway heart rate, concrete activity, exercise and slumber will be used. The participants will habiliment this action tracker for 5–7 days. Currently, the study uses the Fitbit Accuse HR. Data for each subject will be downloaded from the Fitbit Awarding Programming Interface (https://dev.fitbit.com/reference/spider web-api/quickstart)_. Step counts are available at ii levels; intraday footstep counts in 15-min intervals and daily totals. Intraday Hr data are available at 5-min intervals, along with confidence levels. Intraday sleep tracking data containing details of each sleep session volition also exist recorded.

Calcium score

Electron beam CT scanning using face-to-face iii-mm slices during a single jiff hold will be performed by a 320-slice CT scanner (Toshiba Aquilion ONE) with the following parameters: tube voltage 120kVp, tube current 200-400 mA (dependent on patient size and shape as visually assessed past the radiographers), gantry rotation time 350 ms and 3 mm department thickness. The non-contrast scan will be volume prospective and ECG-gated and synchronized to the RR interval with a scan fourth dimension of 100 ms/slice. A calcified lesion volition exist divers as at least ii contiguous voxels with an attenuation coefficient > 130 Hounsfield units. Coronary calcium scores volition exist calculated as previously described [15] via Vitrea Workstation.

Cardiac MRI

Cardiovascular phenotyping using cardiovascular magnetic resonance (CMR) will be performed in all salubrious volunteers (three T Ingenia, Philips or 1.5 T MAGNETOM Aera, Siemens). Conventional balanced steady-land free precession cine images of the vertical and horizontal long-axis planes and the sagittal LV outflow tract view will be caused. Short-centrality cines will be obtained from the mitral valve annulus to the noon (eight mm slices with 2 mm gap). In addition, a single breath hold 3D LV short axis stack will as well be caused in the same orientation. Aortic flow volition be assessed using velocity-coded phase dissimilarity imaging. Cardiac volumes, left ventricular mass, atrial sizes and aortic root will be measured in all patients using the CMR 42 software (Circumvolve Cardiovascular Imaging). Normal CMR reference ranges in the Asian population were recently published using standardized protocols in our Paradigm Analysis Laboratory [16].

Lipidomics studies

twenty μl of lipid internal standard mix and 10 μl of fourteen:0 phosphatidylcholine will exist added to 100 μl of serum in a microcentrifuge tube. Subsequently an equilibration menstruation of 30 s, ane.2 ml of HPLC-grade methanol will be added to the mixture, followed past vortexing. The mixture volition be incubated at fifty °C for ten min, followed by centrifugation to pellet the precipitated protein. The supernatant will and so exist removed and placed in a clean microcentrifuge tube for drying nether nitrogen gas. 100 μl of methanol volition be used to reconstitute the dried extract. The reconstituted lipid solution volition be separated using a LC-MS (liquid chromatography – mass spectrometry) system (Agilent 1260) and a Thermo Scientific Accucore HILIC column (100 × two.1 mm; particle size 2.6 μm). Mobile stage A consists of acetonitrile/water (95:5) with ten mM ammonium acetate, pH viii.0 and mobile stage B consists of acetonitrile/water (50:50) with x mM ammonium acetate, pH 8.0. For the separation, the column will be equilibrated with 100% mobile stage A, increasing to 20% mobile phase B in five min, and so held for 5 min. The column volition finally be re-equilibrated with 100% mobile phase A for 5 min. Finally, mass spectrometry and data conquering will be performed using an Agilent 6430 triple-quadrupole mass spectrometer [17].

Genomics studies

Whole genome sequencing will be done in Illumina HiSeq X sequencers at 30X coverage. i.0 micrograms of DNA per sample will exist used for library preparation. Sequencing libraries will be generated using the Truseq Nano DNA HT sample preparation kit (Illumina, SUA) and idenx codes will exist added to each sample. Briefly, the genome will be fragmented past sonication to a size of 350 bp, and the Deoxyribonucleic acid fragments will be stop-polished, A-tailed and ligated with full-length adapter for Illumina sequencing with farther PCR distension. Lastly, PCR products will exist purified (AMPure XP organisation) and the libraries analysed for size distribution past Agilent 2100 Bioanalyzer and quantified using real-time PCR.

Outcomes

Outcomes volition be tracked six monthly for 20 years via review of medical records. The outcomes studied will include mortality and cause of death, myocardial infarction, stroke, malignancy, centre failure, and the development of comorbidities (due east.1000. ischemic heart disease, peripheral vascular disease, diabetes mellitus, renal failure, etc.). Patients provided explicit consent for the matching of outcomes confronting databases and registries. Data on mortality, myocardial infarction, stroke, chronic kidney illness and malignancy will be obtained from national state-mandated registries (due east.g. Singapore Myocardial Infarction Registry, Singapore Stroke Registry, Singapore Renal Registry, Singapore Cancer Registry, Singapore Renal Registry, etc).

Study management

The SingHEART Steering Committee is responsible for the overall conduct of the study. The protocol blueprint and execution of the study is entirely under the oversight of the SingHEART Steering Committee, and the funding sources take no access to patient-specific information. Because volunteers are fatigued from the Biobank accomplice, the SingHEART program adheres to protocols managing patient data anonymization, patient confidentiality/privacy, incidental finding management; and biosample/genomic Deoxyribonucleic acid samples. Data is entered electronically into a pre-designed database by trained study coordinators and the accuracy of the data will exist regularly audited. Requests to utilize the data or biospecimens for research will require approval from the steering committee in accord with standardized procedures. The report team meets once every month to review study progress and to address any concerns raised by the study coordinators.

Statistics

The initial target enrolment is 2500 based on feasibility and initial funding availability, with the opportunity to extend recruitment with further funding. Multiple linear regression and logistic regression analyses using generalised linear models will be performed to study the relationships betwixt factors. Odds ratios, 95% confidence intervals and p-values will be reported. Cox-proportional hazards models will exist used to analyse longer-term wellness outcomes and hazards ratios reported. Multivariate adjustment for confounders will be performed. Machine learning methodology appropriate for high-dimensionality datasets (e.chiliad. deep learning systems and neural networks, nomenclature techniques involving decision trees and probabilistic prediction) will besides be performed in tandem with conventional statistical analysis.

Preliminary results

From Oct 2015 to May 2017, an initial 400 subjects have been recruited and all have completed the baseline investigations as documented above. Table 2 describes the baseline characteristics of the initial subjects. Further recruitment is currently ongoing and as of February 2018, 683 patients have been recruited.

Table ii Selected baseline characteristics of initial cohort (n = 400)

Full size table

Discussion

In recent times, at that place has been a revolution in healthcare brought about by quantum leaps in technology. This has brought with information technology the unprecedented opportunity to amend characterise and manage diseases and better healthcare. Unlike advancements include the utilize of "bogus intelligence" and "deep learning", the development of molecular medicine with improvements in genomic, metabolomic and proteomic screening and the use of devices like wearables which can constantly monitor diverse physiological data.

As mentioned earlier, in that location have been several collaborations primarily in Western cohorts to tap on this technology boom to better characterise cardiovascular diseases [5,vi,7]. The AHA and GLS aim to leverage on the engineering science and analysis by Google technical capabilities and insights offered past Google Life Sciences to analyze the various aspects of cardiovascular diseases [5]. Project Baseline, a collaboration between Duke, Stanford and Verily, aims to collect broad phenotypic data across multiple domains including continuous sensors from thousands of participants, harnessing the power of technology to do so [half-dozen]. The SingHEART study aims to be one of the most comprehensive phenotypic studies of cardiovascular diseases in the world. We volition characterize phenotypes on multiple fronts including a) questionnaires on lifestyle, diet, exercise information, etc. b) detailed cardiac imaging and investigations including cardiac MRI, 24 h ECG and blood pressure monitoring, and calcium score c) wearables for constant physiological monitoring and d) genomic and lipidomic screening. One of the unique features of SingHEART is the pre-hoc intention to pool information across multiple domains into larger datasets suitable for assay by machine learning algorithms. Early work from this projection on the human relationship between wearable data and cardiovascular risk factors in normal volunteers take recently been published based on this approach [17] which volition provide the foundation for further insights and agreement into the development and prevention of CVD in this cohort.

Beyond the use of technology to narrate cardiovascular diseases, SingHEART affords the opportunity to ameliorate elucidate differences beyond different Asian ethnicities. Indigenous differences have been known to exist across the spectrum of cardiovascular diseases. With regards to heart failure (HF), the Multi-Ethnic Written report of Atherosclerosis (MESA) study found the risk of incident HF to be unlike amid races [8]. Prior studies in Asian patients with HF showed increased agin outcomes in Malays and Indians compared to Chinese [9]. For coronary heart illness (CHD), Whites appear to have higher risk of CHD compared to blacks, Latinos and Asians [8]. A local study institute Indians to have the greatest incidence of myocardial infarction only Malays to have the highest mortality rate [eleven]. SingHEART aims to understand the mechanistic causes behind these ethnic differences. Furthermore, the overlapping influence of genetics and ecology or behavioral factors on the development of disease may be hard to tease out in the traditional setting [12, thirteen]. With growth of technology and genetic research, this separate has been narrowed [12]. Studies like SingHEART with detailed genotypic, phenotypic and socioeconomic characterization will allow the opportunity to study this differentiation in greater depth.

The SingHEART project is the first contemporary population-based written report in Asia that will allow us to harness up-to-engagement technology to better understand the evolution of cardiovascular illness across dissimilar ethnic groups. This will provide invaluable opportunities to develop pertinent public health prevention strategies, guide allotment of healthcare resources, better the diagnosis and direction of cardiovascular disease, and serve equally a foundation for future enquiry.

Availability of data and materials

The datasets generated and/or analyzed during the current study are not publicly bachelor due the ongoing nature of this study, simply are available from the corresponding writer on reasonable request.

Abbreviations

AHA:

American Heart Association

CHD:

Coronary heart disease

CMR:

Cardiovascular magnetic resonance

CT:

Computed tomography

CVD:

Cardiovascular affliction

ECG:

Electrocardiogram

GLS:

Google life sciences

HF:

Heart failure

MESA:

Multi-ethnic report of atherosclerosis

MRI:

Magnetic resonance imaging

NHCS:

National Heart Centre (Singapore)

PRISM:

Establish of Precision Medicine

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Acknowledgements

Nosotros would like to thank the individuals who volunteered for the written report.

Funding

Nosotros would like to thank the Lee foundation for their grant support for the SingHeart report, conducted at National Center Centre Singapore. The work was also supported past core funding from SingHealth and Duke NUS through their establish of Precision Medicine (PRISM) and a center grant awarded to National Center Heart Singapore from the National Medical Research Quango, Ministry building of Health, Commonwealth of Singapore (NMRC/CG/M006/2017_NHCS).

The funding bodies were not involved in design, conduct, data interpretation, or writing of the manuscript.

Author information

Affiliations

1. Cardiology, National Heart Centre Singapore, 5 Hospital Drive, Singapore, 169609, Singapore

   Jonathan Yap, Anders Sahlén, Calvin Woon-Loong Mentum, Kenneth Michael Yun-Chi Chew, John Allen, Vera Goh, Swee Yaw Tan, Carolyn S. P. Lam, Stuart Alexander Cook & Khung Keong Yeo

2. SingHealth Duke-NUS Institute of Precision Medicine, Singapore, Singapore

   Weng Khong Lim, Sonia Davila, Patrick Tan & Stuart Alexander Cook

3. Cancer and Stem Biology Program, Knuckles-NUS Medical School, Singapore, Singapore

   Weng Khong Lim & Patrick Tan

4. Cardiovascular and Metabolic Disorders Program, Duke-NUS Medical Schoolhouse, Singapore, Singapore

   Sonia Davila & Carolyn S. P. Lam

5. Knuckles-NUS Medical School, Singapore, Singapore

   Khung Keong Yeo

Contributions

Study conception and design was performed by JY, WKL, CWLC, SD, PT, CL, SAC, KKY. Data drove was performed by WKL, Every bit, SD, VG and KKY. Analysis was performed by JY, KMYCC, CWLC, JA, PT, SAC and KKY. Writing was performed by JY, KMYCC, SYT, PT, SD, SAC and KKY. This manuscript was read and approved past all credited authors.

Corresponding authors

Correspondence to Kenneth Michael Yun-Chi Chew or Khung Keong Yeo.

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Ethics approval and consent to participate

The enquiry study was performed in accordance with the Declaration of Helsinki, and ethical approval was obtained from the Singhealth institution review board. Written informed consent was obtained from all report participants.

Consent for publication

Non applicable.

Competing interests

C.S.L. is supported past a Clinician Scientist Award from the National Medical Research Council of Singapore; has received research support from Boston Scientific, Bayer, Thermofisher, Medtronic, and Vifor Pharma; and has consulted for Bayer, Novartis, Takeda, Merck, Astra Zeneca, Janssen Research & Development, LLC, Menarini, Boehringer Ingelheim, Abbott Diagnostics, Corvia, Stealth BioTherapeutics, Roche, and Amgen. The residual of the authors take no relevant competing interest to declare.

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Yap, J., Lim, W.K., Sahlén, A. et al. Harnessing technology and molecular analysis to understand the development of cardiovascular diseases in Asia: a prospective cohort study (SingHEART). BMC Cardiovasc Disord 19, 259 (2019). https://doi.org/x.1186/s12872-019-1248-3

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• Received: 09 Feb 2019

• Accepted: 07 Nov 2019

• Published: 21 November 2019

• DOI : https://doi.org/10.1186/s12872-019-1248-3

Keywords

• Primary prevention
• Cardiovascular disease
• Coronary avenue disease
• Epidemiology
• Biomarkers
• Ethnicity
• Imaging

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