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UNdeRstAnding Novel Variants in AcutE MyocardiaL Infarction in Young Adults

UNdeRstAnding Novel Variants in AcutE MyocardiaL Infarction in Young Adults

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06698341
Acronym
UNRAVEL
Enrollment
1200
Registered
2024-11-21
Start date
2024-04-29
Completion date
2028-04-30
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction, Acute

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.

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

Sponsors

National Heart Centre Singapore
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To identify novel gene variants associated with the onset of MI in relatively young patients5 yearsAny new genetic variants through genomic analyses

Secondary

MeasureTime frameDescription
To identify other novel biomarkers such as proteins, lipids and metabolites, associated with MI in young adults5 yearsAny new biomarkers during metabolomics and proteomics analyses

Countries

Singapore

Contacts

Primary ContactTze Theng Goh
goh.tze.theng@nhcs.com.sg67042227

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026