A Biorepository for Coronary Heart Disease in Qatar

NCT03427489 | Completed

• 1 other identifier: NPRP No. : 5 - 1024 - 3 - 225
• Study Type: observational
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary heart disease (CHD) poses a major health burden in the Gulf countries. It is the leading cause of mortality and morbidity in the world and poses an enormous societal burden in the Gulf countries. Early detection of disease is imperative to reduce the health care burden and financial costs associated with CHD. Knowledge of novel genetic and proteomic markers of CHD will provide more precise estimates of risk while defining the pathways important in individual patients, revealing new targets for intervention, and ultimately enabling an individualized approach to care. To translate recent advances in genomics and proteomics into clinical practice, these newly discovered biomarkers will need to be evaluated in patients of diverse ethnic groups with varying characteristics, environmental factors, and medication use. The investigators propose to establish a biorepository of plasma and Deoxyribonucleic acid (DNA) linked to demographic and clinical variables to facilitate biomarker studies of CHD risk, progression, and outcome. The overarching goal in developing the Qatar Cardiovascular Biorepository (QCBio) is to create a resource that fosters research aimed at identifying novel biochemical and genetic markers of CHD. A biorepository with linkage to clinical data will also provide an invaluable resource for cardiovascular research, including genomic and proteomic studies of CHD and development of biomarkers for early detection of disease and personalized drug therapy (pharmacogenetics and pharmacoproteomics).

Conditions

Coronary Heart Disease (CHD)

Keywords

Biomarkers; Genetic Markers; Controls

Outcome Measures

Primary Outcomes (1)

• Identification of genetic variants associated with CHD in Qatari Individuals using whole genome sequencing on the 2000 samples stored at the genetic biorepository over 3 years.

  QCBio will create an unparalleled and unique resource for conducting genomic and studies to identify and validate biomarkers for diagnosis, prognostication, and response to therapy, in Qataris patients who have CHD or at risk

  Three years

Secondary Outcomes (1)

• Identification of circulating markers using plasma proteomic and metabolomic analysis in 2000 Qatari individuals with and without CHD.

  Three years

Study Arms (2)

Coronary heart disease

Qatari individuals presenting with or have a history of an acute coronary syndrome (myocardial infarction or unstable angina) are being recruited as study subjects.

Controls

Ethnicity-matched individuals without history of CHD such as myocardial infarction or prior PCI are being recruited as controls.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Qatari individuals who present with or have a history of an acute coronary syndrome (myocardial infarction or unstable angina) are being recruited as study subjects from the coronary catheterization laboratory (Cath Lab) and the coronary care unit. Ethnicity-matched controls are being recruited from the blood bank where individuals typically undergo screening by means of questionnaires and those with chronic or infectious disease are excluded.

You may qualify if:

• Subjects: History or clinical diagnosis of Acute Coronary Syndrome
• Controls: No history of Coronary Heart disease.

You may not qualify if:

• Chronic or infectious disease
• Vulnerable populations (Children, prisoners, cognitive impairment)

Sponsors & Collaborators

• Hamad Medical Corporation: lead
• Mayo Clinic: collaborator

Study Sites (1)

Hamad Medical Corporation

Doha, 3050, Qatar

Location

Related Publications (14)

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  PMID: 20177011 BACKGROUND

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  PMID: 29062618 BACKGROUND

• Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.

  PMID: 11368702 BACKGROUND

• Kullo IJ, Ballantyne CM. Conditional risk factors for atherosclerosis. Mayo Clin Proc. 2005 Feb;80(2):219-30. doi: 10.4065/80.2.219.

  PMID: 15704777 BACKGROUND

• Cooper RS, Psaty BM. Should ethnicity serve as the basis for clinical trial design? Diversity and inclusiveness should remain the guiding principles for clinical trials. Circulation. 2005 Dec 6;112(23):3660-5; discussion 3665-6. No abstract available.

  PMID: 16333866 BACKGROUND

• Kullo IJ, Cooper LT. Early identification of cardiovascular risk using genomics and proteomics. Nat Rev Cardiol. 2010 Jun;7(6):309-17. doi: 10.1038/nrcardio.2010.53. Epub 2010 May 4.

  PMID: 20440292 BACKGROUND

• Morrison AC, Bare LA, Chambless LE, Ellis SG, Malloy M, Kane JP, Pankow JS, Devlin JJ, Willerson JT, Boerwinkle E. Prediction of coronary heart disease risk using a genetic risk score: the Atherosclerosis Risk in Communities Study. Am J Epidemiol. 2007 Jul 1;166(1):28-35. doi: 10.1093/aje/kwm060. Epub 2007 Apr 18.

  PMID: 17443022 BACKGROUND

• Khoury MJ, Jones K, Grosse SD. Quantifying the health benefits of genetic tests: the importance of a population perspective. Genet Med. 2006 Mar;8(3):191-5. doi: 10.1097/01.gim.0000206278.37405.25. No abstract available.

  PMID: 16540755 BACKGROUND

• Cortese DA. A vision of individualized medicine in the context of global health. Clin Pharmacol Ther. 2007 Nov;82(5):491-3. doi: 10.1038/sj.clpt.6100390.

  PMID: 17952101 BACKGROUND

• Ginsburg GS, Burke TW, Febbo P. Centralized biorepositories for genetic and genomic research. JAMA. 2008 Mar 19;299(11):1359-61. doi: 10.1001/jama.299.11.1359. No abstract available.

  PMID: 18349099 BACKGROUND

• Ding K, Kullo IJ. Genome-wide association studies for atherosclerotic vascular disease and its risk factors. Circ Cardiovasc Genet. 2009 Feb;2(1):63-72. doi: 10.1161/CIRCGENETICS.108.816751. No abstract available.

  PMID: 19750184 BACKGROUND

• Kim CX, Bailey KR, Klee GG, Ellington AA, Liu G, Mosley TH Jr, Rehman H, Kullo IJ. Sex and ethnic differences in 47 candidate proteomic markers of cardiovascular disease: the Mayo Clinic proteomic markers of arteriosclerosis study. PLoS One. 2010 Feb 5;5(2):e9065. doi: 10.1371/journal.pone.0009065.

  PMID: 20140090 BACKGROUND

• Evans BJ, Meslin EM. Encouraging translational research through harmonization of FDA and common rule informed consent requirements for research with banked specimens. J Leg Med. 2006 Jun;27(2):119-66. doi: 10.1080/01947640600716366. No abstract available.

  PMID: 16728351 BACKGROUND

• Kullo IJ, Fan J, Pathak J, Savova GK, Ali Z, Chute CG. Leveraging informatics for genetic studies: use of the electronic medical record to enable a genome-wide association study of peripheral arterial disease. J Am Med Inform Assoc. 2010 Sep-Oct;17(5):568-74. doi: 10.1136/jamia.2010.004366.

  PMID: 20819866 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

We intend to establish a DNA and plasma repository of 1000 Qatari CHD cases and 1000 ethnicity-matched controls (QCBio) to enable investigation of genomic and proteomic biomarkers for early detection and prognostication and to identify new targets for drug development.

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Iftikhar Kullo

  Mayo Clinic College of Medicine

  PRINCIPAL INVESTIGATOR

• Ayman El-Menyar

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

• Jassim Al Suwaidi

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 1, 2018
• First Posted: February 9, 2018
• Study Start: January 31, 2013
• Primary Completion: March 18, 2018
• Study Completion: March 18, 2018
• Last Updated: August 1, 2018

Record last verified: 2018-07

Locations

QA (1)