NCT05775445Recruiting
Extremes of Coronary Artery Disease and Normality:CAD Extremes
Extremes of Coronary Artery Disease and Normality: Understanding Novel Causative and Protective Factors in the Development of Coronary Artery Disease (CAD Extremes)
Source: ClinicalTrials.gov · Last updated 21 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In the field of cardiovascular medicine, there are two differing groups of patients that remain puzzling to clinicians: patients who are not expected to have coronary artery disease (CAD) yet are diagnosed with significant CAD; and those who are have multiple risk factors for CAD but do not have CAD. Bats exhibit unique phenotypes including long lifespans and likely reduced atherosclerosis. Prior work has identified multiple molecular mechanisms of suppressing the activation of inflammasomes, causally linked to atherosclerosis. The investigators hypothesize there are different molecular markers that confer protection or increased risk for CAD, some of which may be similar to bats. Thus, the aim of this study is to identify molecular markers that contribute to or are protective against acute coronary syndrome (ACS) through analyzing the genetics, peripheral blood and atherosclerotic samples from both extreme patient groups using single-cell RNA sequencing and multi-omics approach. In addition, novel anti-atherosclerotic mechanisms and factors from bat studies will be assessed in the human samples. Identification of novel targets that prevent or cause CAD has the potential to aid in the early identification of high-risk patients and development of new therapeutics to combat this growing epidemic. To conduct this study, patients who have undergone a coronary angiogram or a CT coronary angiogram that fall into the both extremes will be recruited and blood samples will be taken for the above analysis. These will be compared to a group of controls (low risk without disease and high risk with disease).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 10 Feb 2023
- Start date
- 30 May 2023
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- National Heart Centre Singapore
- Diseases
- Coronary artery disease
- NCT number
- NCT05775445
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 30 May 2023 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Prior history of cancer (excludes pre-cancerous lesions)
- Known autoimmune disease
- Psychiatric illness
- Chronic lung disease requiring long term medications or oxygen
- Chronic infective disease, including tuberculosis, hepatitis B and C; and HIV
- Any other acute or chronic medical or physical condition deemed by the investigator to affect study outcomes
Other
- Expected life expectancy less than 1 year
- Inability to comply with study protocol
Who the study is looking for
- Group 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
- Age \</= 45 for males and \</= 50 for females
- Absence of diabetes mellitus
- Absence of tobacco use
- No prior CVA or PAD
- Group 2
- Evidence of significant CAD
- 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
- Age \</= 45 for males and \</= 50 for females
- Absence of diabetes mellitus
- Absence of tobacco use
- No prior CVA or PAD
- Group 3 1. Evidence of significant CAD with one of the following:
- age\>65
- Diabetes mellitus
- End Stage Renal Failure (ESRF)
- Framingham risk score \>10%
- Group 4
- 1\. No evidence of significant CAD and all of the following
- Age \<55 for males, \<65 for females
- Absence of diabetes mellitus
- Absence of CKD
- Absence of tobacco use
Age in the registry: 21 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Heart Centre Singapore Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.