Coronary Artery Disease Clinical Trial
Official title:
Extremes of Coronary Artery Disease and Normality: Understanding Novel Causative and Protective Factors in the Development of Coronary Artery Disease (CAD Extremes)
NCT number | NCT05775445 |
Other study ID # | 2022/2366 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 30, 2023 |
Est. completion date | December 2027 |
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 | Recruiting |
Enrollment | 1500 |
Est. completion date | December 2027 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Singapore | National Heart Centre Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
National Heart Centre Singapore | Duke-NUS Graduate Medical School |
Singapore,
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. — View Citation
Duewell P, Kono H, Rayner KJ, Sirois CM, Vladimer G, Bauernfeind FG, Abela GS, Franchi L, Nunez G, Schnurr M, Espevik T, Lien E, Fitzgerald KA, Rock KL, Moore KJ, Wright SD, Hornung V, Latz E. NLRP3 inflammasomes are required for atherogenesis and activated by cholesterol crystals. Nature. 2010 Apr 29;464(7293):1357-61. doi: 10.1038/nature08938. Erratum In: Nature. 2010 Jul 29;466(7306):652. — View Citation
Paulin N, Viola JR, Maas SL, de Jong R, Fernandes-Alnemri T, Weber C, Drechsler M, Doring Y, Soehnlein O. Double-Strand DNA Sensing Aim2 Inflammasome Regulates Atherosclerotic Plaque Vulnerability. Circulation. 2018 Jul 17;138(3):321-323. doi: 10.1161/CIRCULATIONAHA.117.033098. No abstract available. — View Citation
Widmaier EP, Gornstein ER, Hennessey JL, Bloss JM, Greenberg JA, Kunz TH. High plasma cholesterol, but low triglycerides and plaque-free arteries, in Mexican free-tailed bats. Am J Physiol. 1996 Nov;271(5 Pt 2):R1101-6. doi: 10.1152/ajpregu.1996.271.5.R1101. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Using sequencing analysis to develop treatment to protect against Coronary artery disease | To use advanced genomic, metabolomics, proteomic and single-cell RNA sequencing (scRNA-seq) analysis to understand novel factors influencing the development of coronary artery disease, as well as protection against coronary artery disease | 5 years | |
Primary | Develop treatment for Coronary artery disease | To aid in the development of novel preventive and treatment strategies for coronary artery disease | 5 years |
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