A Multi-omics Study of "Healthy" Premature CAD Patients
NCT ID: NCT06362278
Last Updated: 2024-04-12
Study Results
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Basic Information
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RECRUITING
160 participants
OBSERVATIONAL
2024-03-20
2025-12-31
Brief Summary
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The main questions it aims to answer are:
* Genetic risk factors \& metabolic fingerprints of patients with premature CAD and none traditional CAD risk factors remain unknown.
* How to optimize current primary prevention strategy for this rare CAD subgroup？
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Detailed Description
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It is now widely known that risk factors such as diabetes mellitus, hyperlipidemia, hypertension, smoking, and obesity are closely related to CAD, but they only explain 30%-40% of CAD risk factors, and large-sample cohort and twin studies have concluded that CAD heritability is estimated to be 40% to 60%. With the development of the Human Genome Project and high-throughput sequencing technology, in the past decade, increasingly larger genome-wide association studies (GWAS) have been conducted worldwide and biobanks established. Public sequencing data is increasingly being used as external common controls instead of sequencing new controls in every study. Till now, thousands of mutations related to CAD have been identified. Multiple Polygenic risk scores (PRSs) have been developed to improve the prediction of common, complex cardiovascular diseases like CAD on individual level.
Premature CAD has been proved to have strong link with family history of cardiovascular and cerebral vascular disease, which indicates a strong genetic background of premature CAD. However, there is an even more scarce \& inconspicuous subgroup of premature CAD, defined as premature CAD without common CAD risk factors in this study. First of all, most of those patients were considered "healthy" or "at very low risk of CVDs" before CAD was diagnosed; secondly, genetic risk factors \& metabolic fingerprints of such patients remain unknown; thirdly, we still don't know yet how to optimize current primary prevention strategy for this rare CAD subgroup.
For this regard, we designed this multi-omics study to cover the questions mentioned above.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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cases group
In-patients from cardiology department of The First Affiliated Hospital with Nanjing Medical University will be screened using inclusion/exclusion criteria for patients. Among the patients who meet the criteria and willing to give an informed consent, 30 patients with youngest CAD-diagnosed-age will be enrolled as cases.
multi-omics studies
15cc peripheral venous blood will be collected for multi-omics studies, including whole-exome study, transcriptomics \& metabolomics studies.
matching controls group
In-patients from cardiology department of The First Affiliated Hospital with Nanjing Medical University will be screened using inclusion/exclusion criteria for controls. 30 controls matched in gender and age will be enrolled as matching controls.
multi-omics studies
15cc peripheral venous blood will be collected for multi-omics studies, including whole-exome study, transcriptomics \& metabolomics studies.
verification group
In-patients from cardiology departments of all 3 centers will be screened using inclusion/exclusion criteria. Other than previous 60 participants, about another 100 patients and controls in total who meet the criteria and willing to give an informed consent will be enrolled as verification group.
multi-omics studies
15cc peripheral venous blood will be collected for multi-omics studies, including whole-exome study, transcriptomics \& metabolomics studies.
Interventions
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multi-omics studies
15cc peripheral venous blood will be collected for multi-omics studies, including whole-exome study, transcriptomics \& metabolomics studies.
Eligibility Criteria
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Inclusion Criteria
2. Confirmed diagnosis of Obstructive CAD (≥50% diameter stenosis in a major epicardial vessel) through coronary angiography
3. Age of the patient when Obstructive CAD was for the first time diagnosed should be no more than 45 years old for the male and 55 years old for the female.
1. In-patients from cardiology department of either following 3 hospitals: a) The First Affiliated Hospital of Nanjing Medical University; b) Qilu Hospital of Shandong University; c) The Second Affiliated Hospital Zhejiang University School of Medicine
2. Coronary artery stenosis was ruled out through either coronary angiography or coronary CTA.
Exclusion Criteria
2. Patients with type 1 or type 2 diabetes mellitus
3. BMI \>28.0 Kg/m\^2
4. Patients with non-ideal blood lipids level on admission(defined as either LDL-C≥2.6mmol/L OR non-HDL cholesterol≥3.4mmol/L OR Lipoprotein(a) ≥300mg/L)
5. Smoker (Smoking for more than 6 consecutive or cumulative months in a lifetime, whether quit smoking or not)
6. Patients with hyperuricemia or gout
7. eGFR\<60 ml/min·1.73m\^2
8. Patients with structural heart diseases, inherited cardiomyopathies \& arrhythmias
9. Other reasons a participant considered unsuitable for inclusion by researchers.
18 Years
75 Years
ALL
Yes
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Chunjian Li
Director of Cardiology
Principal Investigators
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Chunjian Li, PHD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Qilu Hospital of Shangdong University
Jinan, Shandong, China
The Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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References
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Mensah GA, Fuster V, Murray CJL, Roth GA; Global Burden of Cardiovascular Diseases and Risks Collaborators. Global Burden of Cardiovascular Diseases and Risks, 1990-2022. J Am Coll Cardiol. 2023 Dec 19;82(25):2350-2473. doi: 10.1016/j.jacc.2023.11.007. No abstract available.
Kessler T, Vilne B, Schunkert H. The impact of genome-wide association studies on the pathophysiology and therapy of cardiovascular disease. EMBO Mol Med. 2016 Jul 1;8(7):688-701. doi: 10.15252/emmm.201506174. Print 2016 Jul.
O'Sullivan JW, Raghavan S, Marquez-Luna C, Luzum JA, Damrauer SM, Ashley EA, O'Donnell CJ, Willer CJ, Natarajan P; American Heart Association Council on Genomic and Precision Medicine; Council on Clinical Cardiology; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Lifestyle and Cardiometabolic Health; and Council on Peripheral Vascular Disease. Polygenic Risk Scores for Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2022 Aug 23;146(8):e93-e118. doi: 10.1161/CIR.0000000000001077. Epub 2022 Jul 18.
Muse ED, Chen SF, Torkamani A. Monogenic and Polygenic Models of Coronary Artery Disease. Curr Cardiol Rep. 2021 Jul 1;23(8):107. doi: 10.1007/s11886-021-01540-0.
Saadatagah S, Varughese MG, Nambi V. Coronary Artery Disease Risk Prediction in Young Adults: How Can We Overcome the Dominant Effect of Age? Curr Atheroscler Rep. 2023 Jun;25(6):257-265. doi: 10.1007/s11883-023-01106-1. Epub 2023 May 17.
Vilne B, Schunkert H. Integrating Genes Affecting Coronary Artery Disease in Functional Networks by Multi-OMICs Approach. Front Cardiovasc Med. 2018 Jul 17;5:89. doi: 10.3389/fcvm.2018.00089. eCollection 2018.
Collet JP, Zeitouni M, Procopi N, Hulot JS, Silvain J, Kerneis M, Thomas D, Lattuca B, Barthelemy O, Lavie-Badie Y, Esteve JB, Payot L, Brugier D, Lopes I, Diallo A, Vicaut E, Montalescot G; ACTION Study Group. Long-Term Evolution of Premature Coronary Artery Disease. J Am Coll Cardiol. 2019 Oct 15;74(15):1868-1878. doi: 10.1016/j.jacc.2019.08.1002.
Navas-Nacher EL, Colangelo L, Beam C, Greenland P. Risk factors for coronary heart disease in men 18 to 39 years of age. Ann Intern Med. 2001 Mar 20;134(6):433-9. doi: 10.7326/0003-4819-134-6-200103200-00007.
Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e596-e646. doi: 10.1161/CIR.0000000000000678. Epub 2019 Mar 17. No abstract available.
Singh A, Collins BL, Gupta A, Fatima A, Qamar A, Biery D, Baez J, Cawley M, Klein J, Hainer J, Plutzky J, Cannon CP, Nasir K, Di Carli MF, Bhatt DL, Blankstein R. Cardiovascular Risk and Statin Eligibility of Young Adults After an MI: Partners YOUNG-MI Registry. J Am Coll Cardiol. 2018 Jan 23;71(3):292-302. doi: 10.1016/j.jacc.2017.11.007. Epub 2017 Nov 12.
Wojcik GL, Murphy J, Edelson JL, Gignoux CR, Ioannidis AG, Manning A, Rivas MA, Buyske S, Hendricks AE. Opportunities and challenges for the use of common controls in sequencing studies. Nat Rev Genet. 2022 Nov;23(11):665-679. doi: 10.1038/s41576-022-00487-4. Epub 2022 May 17.
Other Identifiers
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026
Identifier Type: -
Identifier Source: org_study_id
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