Exploring the extremes of coronary artery disease

Extremes of Coronary Artery Disease and Normality: Understanding Novel Causative and Protective Factors in the Development of Coronary Artery Disease (CAD Extremes)

This study is trying to find out why some people with coronary artery disease have serious issues despite not having common risk factors, while others with many risk factors have little to no disease, by looking at their genes and blood samples.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 21 Years to 99 Years
• Sex: All
• Sponsor: National Heart Centre Singapore (Academic / other)
• Locations: 1 site (Singapore)
• Trial ID: NCT05775445 on ClinicalTrials.gov

What this trial studies

This observational study investigates two distinct groups of patients with coronary artery disease (CAD): those who have significant CAD despite low risk factors and those with multiple risk factors but little to no CAD. The researchers aim to identify molecular markers that may contribute to or protect against acute coronary syndrome (ACS) by analyzing genetic, blood, and atherosclerotic samples from these extreme patient groups. Utilizing single-cell RNA sequencing and a multi-omics approach, the study seeks to uncover insights into the mechanisms underlying these contrasting phenotypes. The findings could enhance understanding of CAD and inform future therapeutic strategies.

Who should consider this trial

Good fit: Ideal candidates include young adults with significant CAD but no traditional risk factors, as well as older patients with significant CAD and established risk factors.

Not a fit: Patients with well-established coronary artery disease and multiple risk factors who do not fit the extreme profiles may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the identification of new biomarkers for coronary artery disease, improving risk assessment and treatment strategies for patients.

How similar studies have performed: While the study's approach is innovative, previous research has explored similar themes in understanding CAD, though this specific focus on extreme phenotypes is relatively novel.

Eligibility criteria

Inclusion Criteria:

Group 1:

1. Evidence of significant CAD a. Coronary angiogram or CT coronary angiogram with documented stenosis \>=50% in left main or \>=70% in major epicardial vessel or major branches (LAD, LCX, RCA)

   AND all of the following
2. Age \</= 45 for males and \</= 50 for females
3. Absence of diabetes mellitus
4. Absence of tobacco use
5. No prior CVA or PAD

Group 2

1. Evidence of significant CAD

   1. Coronary angiogram or CT coronary angiogram with documented stenosis \>=50% in left main or \>=70% in major epicardial vessel or major branches (LAD, LCX, RCA)

   AND all of the following
2. Age \</= 45 for males and \</= 50 for females
3. Absence of diabetes mellitus
4. Absence of tobacco use
5. No prior CVA or PAD

Group 3 1. Evidence of significant CAD with one of the following:

1. age\>65
2. Diabetes mellitus
3. End Stage Renal Failure (ESRF)
4. Framingham risk score \>10%

Group 4

1\. No evidence of significant CAD and all of the following

1. Age \<55 for males, \<65 for females
2. Absence of diabetes mellitus
3. Absence of CKD
4. Absence of tobacco use

Exclusion Criteria:

1. Prior history of cancer (excludes pre-cancerous lesions)
2. Expected life expectancy less than 1 year
3. Known autoimmune disease
4. Psychiatric illness
5. Chronic lung disease requiring long term medications or oxygen
6. Chronic infective disease, including tuberculosis, hepatitis B and C; and HIV
7. Inability to comply with study protocol
8. Any other acute or chronic medical or physical condition deemed by the investigator to affect study outcomes

Where this trial is running

Singapore

• National Heart Centre Singapore — Singapore, Singapore (Recruiting)

Study contacts

• Principal investigator: Khyung Keong Yeo — National Heart Centre
• Study coordinator: Aishah Toh

Conditions Coronary Artery Disease