UNdeRstAnding Novel Variants in AcutE MyocardiaL Infarction in Young Adults

NCT ID: NCT06698341

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-29

Study Completion Date

2028-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Infarction, Acute

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

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

Blood Draw

Intervention Type PROCEDURE

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

Group 2

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

Blood Draw

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood 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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart Centre Singapore

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jonathan Yap

Role: PRINCIPAL_INVESTIGATOR

National Heart Centre Singapore

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Heart Centre Singapore

Singapore, , Singapore

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Singapore

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tze Theng Goh

Role: CONTACT

67042227 ext. 2227

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jonathan Yap

Role: primary

Goh Tze Theng

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21074258 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20826242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15769774 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20032323 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21378986 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12426569 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023/00687

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.