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RecruitingNCT06698341UNRAVELUpdated Nov 21, 2024

UNdeRstAnding Novel Variants in AcutE MyocardiaL Infarction in Young Adults

An observational study in Myocardial Infarction, Acute, sponsored by National Heart Centre Singapore. Recruiting at 1 site in Singapore. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by National Heart Centre Singapore · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
1,200
Ages
21 Years to 60 Years
Sex
All
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Study summary

Cardiovascular disease (CVD) imposes significant mortality and morbidity worldwide. However, large gaps in our knowledge of CVD still exist. The clinical conundrum of the extremes of spectrums of CVD continues to baffle clinicians and researchers alike. These include patients without any major cardiovascular (CV) risk factors developing acute myocardial infarction (AMI) at a relatively young age (\<50-60 years old), while at the other end of the spectrum, there are also patients with multiple CV risk factors but with minor or no coronary artery disease. These suggest the presence of other factors that predispose these patients to AMI.Recent advancements in technology, especially in the field of genomics, metabolomics, and proteomics, have led to exciting developments in our understanding of the development and prevention of CVD and AMI. In this study, the investigators aim to identify novel gene variants associated with the onset of MI in relatively young patients with minimal standard CV risk factors such as diabetes, obesity, hypertension and hypercholesterolaemia.Through genomic, metabolomics and proteomics analyses, this may better improve our understanding of the development of CVD and AMI, potentially developing novel preventive measures to reduce the risk or delay the onset as well as tailoring management plans to improve treatment outcomes and reduce adverse events for the patients.

Read the detailed description

Cardiovascular disease (CVD) imposes significant mortality and morbidity worldwide. Large population-based studies in Western cohorts have formed the foundations of our knowledge on the traditional risk factors of cardiovascular disease. Despite this, large gaps in our knowledge of CVD still exist. The clinical conundrum of the extremes of spectrums of CVD continues to baffle clinicians and researchers alike. These include patients without any major cardiovascular (CV) risk factors developing acute myocardial infarction (AMI) at a relatively young age (\<50-60 years old). At the other end of the spectrum, there are patients with a "full-house" CV risk factors with minor or no coronary artery disease. These suggest the presence of other factors that predispose these patients to AMI.Recent advancements in technology have led to exciting developments in our understanding of the development and prevention of CVD and AMI. The use of "big data" and "deep learning", advancements in genomics, metabolomics, and proteomics have the possibility of transforming this field. Modern prospective population-based studies aim to reclassify CV risk using integrated clinical and molecular biosignatures. However, these studies are based primarily in Western populations. Ethnic differences in CVD exist and currently in Asia, there is a dearth of such advanced data. In addition, in the Singapore Myocardial Infarction Registry (SMIR), it was reported about 1 in 4 of the AMI patients were aged 60 years or less from 2016 to 2020. The average number of AMI cases were about 900 and 2000 in patients aged \< 50 years and aged between 50-59 years respectively. In term of ethnic distribution of the AMI population, about 50% of young AMI patients were Chinese, followed by Malays and Indian. In this study, the investigators specifically aim to identify novel gene variants and novel protein/metabolite candidates associated with the onset of MI in relatively young Chinese,Malay and Indian patients with minimal standard CV risk factors such as diabetes, obesity, hypertension and hypercholesterolaemia. Through these omics-based analyses, these may therefore seek to help answer some of these questions and better improve our understanding of the development of CVD and MI, potentially developing novel preventive measures to reduce the risk or delay the onset and tailoring management plans to improve treatment outcomes and reduce adverse events for the young patients.

02

Conditions studied

  • Myocardial Infarction, Acute
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

National Heart Centre Singapore is the lead sponsor of 61 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Relatively young patients with minimal cardiovascular risk factors who develop AMI from the respective public hospitals in Singapore

Inclusion criteria

  1. Adult >21 years old.
  2. Age ≤50 years old irrespective of the presence of CV risk factors* at the time of myocardial infarction OR Age 51-60 years old with no more than 2 CV risk factor* at the time of myocardial infarction, excluding diabetes mellitus
  3. Able to provide informed consent.
  4. Patients who are willing and able to comply with the study visit and procedures.
  5. Prior type 1 myocardial infarction with angiographically/CT documented significant stenosis of ≥50% in LM or ≥70% in major epicardial/branch vessel (e.g. LAD, LCX, RCA).
  6. Patients who are from the three main races (Chinese, Malay, Indian). Race is self-identified by patient.

    • Hypertension, hyperlipidemia, diabetes mellitus, obesity, current smoker

Exclusion criteria

Exclusion Criteria:

  1. Known familial hypercholesterolaemia, known vasculitides, end-stage renal disease and congenital heart disease.
  2. Prior PAD and Stroke
  3. Female patients who are pregnant
  4. Patients who are non-Asian
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
1,200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Group 1

    Age ≤50 years old irrespective of the presence of CV risk factors\* at the time of myocardial infarction

    Procedure: Blood Draw

  • Group 2

    Age 51-60 years old with no more than 2 CV risk factor at the time of myocardial infarction, excluding diabetes mellitus

    Procedure: Blood Draw

Interventions

  • ProcedureBlood Draw

    3X 6mL K2-EDTA tubes, 1X 3mL K2-EDTA tubes and 1X 3.5mL SST tube - 24.5ml of blood will be collected from patient

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What researchers measure

Primary outcomes

  1. To identify novel gene variants associated with the onset of MI in relatively young patients

    Any new genetic variants through genomic analyses

    Time frame: 5 years

Secondary outcomes

  1. To identify other novel biomarkers such as proteins, lipids and metabolites, associated with MI in young adults

    Any new biomarkers during metabolomics and proteomics analyses

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Alwan A, Maclean DR, Riley LM, d'Espaignet ET, Mathers CD, Stevens GA, Bettcher D. Monitoring and surveillance of chronic non-communicable diseases: progress and capacity in high-burden countries. Lancet. 2010 Nov 27;376(9755):1861-8. doi: 10.1016/S0140-6736(10)61853-3. Epub 2010 Nov 10. PubMed 21074258 ↗
  • Shah SH, Granger CB, Hauser ER, Kraus WE, Sun JL, Pieper K, Nelson CL, Delong ER, Califf RM, Newby LK; MURDOCK Horizon 1 Cardiovascular Disease Investigators. Reclassification of cardiovascular risk using integrated clinical and molecular biosignatures: Design of and rationale for the Measurement to Understand the Reclassification of Disease of Cabarrus and Kannapolis (MURDOCK) Horizon 1 Cardiovascular Disease Study. Am Heart J. 2010 Sep;160(3):371-379.e2. doi: 10.1016/j.ahj.2010.06.051. PubMed 20826242 ↗
  • Bild DE, Detrano R, Peterson D, Guerci A, Liu K, Shahar E, Ouyang P, Jackson S, Saad MF. Ethnic differences in coronary calcification: the Multi-Ethnic Study of Atherosclerosis (MESA). Circulation. 2005 Mar 15;111(10):1313-20. doi: 10.1161/01.CIR.0000157730.94423.4B. PubMed 15769774 ↗
  • Clarke R, Peden JF, Hopewell JC, Kyriakou T, Goel A, Heath SC, Parish S, Barlera S, Franzosi MG, Rust S, Bennett D, Silveira A, Malarstig A, Green FR, Lathrop M, Gigante B, Leander K, de Faire U, Seedorf U, Hamsten A, Collins R, Watkins H, Farrall M; PROCARDIS Consortium. Genetic variants associated with Lp(a) lipoprotein level and coronary disease. N Engl J Med. 2009 Dec 24;361(26):2518-28. doi: 10.1056/NEJMoa0902604. PubMed 20032323 ↗
  • Wang F, Xu CQ, He Q, Cai JP, Li XC, Wang D, Xiong X, Liao YH, Zeng QT, Yang YZ, Cheng X, Li C, Yang R, Wang CC, Wu G, Lu QL, Bai Y, Huang YF, Yin D, Yang Q, Wang XJ, Dai DP, Zhang RF, Wan J, Ren JH, Li SS, Zhao YY, Fu FF, Huang Y, Li QX, Shi SW, Lin N, Pan ZW, Li Y, Yu B, Wu YX, Ke YH, Lei J, Wang N, Luo CY, Ji LY, Gao LJ, Li L, Liu H, Huang EW, Cui J, Jia N, Ren X, Li H, Ke T, Zhang XQ, Liu JY, Liu MG, Xia H, Yang B, Shi LS, Xia YL, Tu X, Wang QK. Genome-wide association identifies a susceptibility locus for coronary artery disease in the Chinese Han population. Nat Genet. 2011 Mar 6;43(4):345-9. doi: 10.1038/ng.783. PubMed 21378986 ↗
  • Ozaki K, Ohnishi Y, Iida A, Sekine A, Yamada R, Tsunoda T, Sato H, Sato H, Hori M, Nakamura Y, Tanaka T. Functional SNPs in the lymphotoxin-alpha gene that are associated with susceptibility to myocardial infarction. Nat Genet. 2002 Dec;32(4):650-4. doi: 10.1038/ng1047. Epub 2002 Nov 11. Erratum In: Nat Genet. 2003 Jan;33(1):107. PubMed 12426569 ↗

Individual participant data

Plan to share: No — Participants will be assigned to a research ID, that only research coordinators and team knows

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06698341
Lead sponsor
National Heart Centre Singapore
Responsible party
Sponsor
First posted
Nov 21, 2024
Start date
Apr 29, 2024
Primary completion
Apr 2026 (estimated)
Completion
Apr 2028 (estimated)
Last update
Nov 21, 2024

Study contacts

Tze Theng Goh
Contact
goh.tze.theng@nhcs.com.sg
67042227 ext. 2227
Jonathan Yap
principal investigator · National Heart Centre Singapore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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