UNdeRstAnding Novel Variants in AcutE MyocardiaL Infarction in Young Adults

Recruiting

• Conditions: Myocardial Infarction, Acute

• Registration Number: NCT06698341
• Lead Sponsor: National Heart Centre Singapore

Brief 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.

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.

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-04-29
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify novel gene variants associated with the onset of MI in relatively young patients	5 years	Any new genetic variants through genomic analyses

Secondary Outcome Measures

Name	Time	Method
To identify other novel biomarkers such as proteins, lipids and metabolites, associated with MI in young adults	5 years	Any new biomarkers during metabolomics and proteomics analyses

Trial Locations

Locations (1)

National Heart Centre Singapore; 🇸🇬 Singapore, Singapore