UNdeRstAnding Novel Variants in AcutE MyocardiaL Infarction in Young Adults

NCT06698341 | Recruiting

• 1 other identifier: 2023/00687
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction, Acute

Outcome Measures

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

  5 years

Secondary Outcomes (1)

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

  5 years

Study Arms (2)

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

Blood Draw 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 1; Group 2

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Adult \>21 years old.
• 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
• Able to provide informed consent.
• Patients who are willing and able to comply with the study visit and procedures.
• 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).
• Patients who are from the three main races (Chinese, Malay, Indian). Race is self-identified by patient.
• Hypertension, hyperlipidemia, diabetes mellitus, obesity, current smoker

You may not qualify if:

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

Sponsors & Collaborators

• National Heart Centre Singapore: lead

Study Sites (1)

National Heart Centre Singapore

Singapore, Singapore

RECRUITING

Related Publications (6)

• 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.

  PMID: 21074258 BACKGROUND

• 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.

  PMID: 20826242 BACKGROUND

• 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.

  PMID: 15769774 BACKGROUND

• 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.

  PMID: 20032323 BACKGROUND

• 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.

  PMID: 21378986 BACKGROUND

• 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.

  PMID: 12426569 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

3X 6mL K2-EDTA tubes, 1X 3mL K2-EDTA tubes and 1X 3.5mL SST tube will be collected per subject

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jonathan Yap

  National Heart Centre Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tze Theng Goh

CONTACT

67042227; goh.tze.theng@nhcs.com.sg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 21, 2024
• Study Start: April 29, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 21, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)