GeneBank at the Cleveland Clinic: Molecular Determinants of Coronary Artery Disease

NCT00590200 | Active Not Recruiting DMC

• 3 other identifiers: IRB 42655P50HL077107-02GeneBank
• Study Type: observational
• Target: 9,880
• Locations: 0 countries
• Sites: N/A

Brief Summary

This proposal delineates a research plan to collect blood from patients undergoing heart catheterization or who have had a heart catheterization within one year and are coming in for outpatient appointments, or who have scheduled cardiac CT scans at the Cleveland Clinic over a five-year period for the purpose of establishing a gene bank registry. In addition, the University of North Carolina at Chapel Hill will enroll 1,000 non-Caucasian patients and MetroHealth Medical center in Cleveland will enroll 1,000 non-Caucasian patients. The blood collected will be processed to create a repository of DNA, lymphoblastoid cell line immortalization on selected patient populations, plasma and serum. The DNA will be amplified in certain patient populations to preserve the quantity. Along with a sample of blood collected from individual patients, a concise general medical history, demographic data, electrocardiographic data, echocardiographic data (available for about 55% of patients at the present time), and laboratory data will be collected. A short interview will take place after enrollment during the outpatient visit or hospital stay, or may be conducted via phone call after enrollment. All the clinical data gathered will be compiled in GATC heart center database, and would be stored in a format where a culmination of clinical findings, i.e. representing a disease of interest, can be used to search the database to identify the blood samples of all patients with such characteristics for further study.

Conditions

Cardiovascular Diseases

Keywords

CAD; Cardiovascular Disease; CVD; MI; Myocardial Infarction; Heart Attack; CABG; Revascularization; genetic

Outcome Measures

Primary Outcomes (1)

• Coronary Artery Disease

  Development of Coronary Artery Disease

  3 years

Secondary Outcomes (4)

• Death

  5 years

• Revascularization

  3 years

• Percutaneous Coronary Intervention/Stent

  3 years

• Myocardial Infarction

  3 years

Eligibility Criteria

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

Study Population

All Cleveland Clinic patients undergoing cardiac catheterization or have had a heart catheterization within one year, coming in for outpatient appointments, or have scheduled cardiac CT scans or CT scans performed within one year of scheduled blood draw, will be eligible to be enrolled.

You may qualify if:

• Males or females at least 18 years old.
• Patient has not been previously enrolled in the genebank registry.
• Patient able to give informed consent.
• Patient to undergo cardiac catheterization or had a left heart cath at The Cleveland Clinic or at The University of North Carolina at Chapel Hill, or at MetroHealth Medical Center within 1 year.
• Patients \> or = to 50 y/o with normal cardiac catheterizations (\< 30% in all coronary vessels per angio). (If subjects enrolled as normal controls are later deemed to have significant CAD, the subject's blood and data will still be useful in the Genebank under the broader scope of the study).
• Any patient with history of myocardial infarction. (If a subject reports history of MI at another facility, outside records will be obtained to confirm the diagnosis. If MI cannot be confirmed by data in the record, the subject's blood and data will still be useful in the Genebank under the broader scope of the study).
• Non-caucasian patients or of Hispanic Ethnicity (UNC and MetroHealth Medical; Center only).
• Any patients coming to the Heart and Vascular Institute for outpatient scheduled appointments.
• Any patients that have had or are going to have an implanted cardioverter defibrillator (ICD) or Cardiac Resynchronization Defibrillator (CRT-D).
• Any patients with cardiac arrhythmias or a family history of cardiac arrhythmias.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Institutes of Health (NIH): collaborator
• Millennium Pharmaceuticals, Inc.: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Related Publications (2)

• Witkowski M, Wu Y, Hazen SL, Tang WHW. Prognostic value of subclinical myocardial necrosis using high-sensitivity cardiac troponin T in patients with prediabetes. Cardiovasc Diabetol. 2021 Aug 21;20(1):171. doi: 10.1186/s12933-021-01365-9.

  PMID: 34419046 DERIVED

• Dupont M, Wu Y, Hazen SL, Tang WH. Cystatin C identifies patients with stable chronic heart failure at increased risk for adverse cardiovascular events. Circ Heart Fail. 2012 Sep 1;5(5):602-9. doi: 10.1161/CIRCHEARTFAILURE.112.966960. Epub 2012 Aug 16.

  PMID: 22899766 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Approximately 70 mls of blood will be dispensed as follows (Approximately 80 mls if cell lines are drawn or if the patient is having a cardiac CT scan): 4 x 10 mls EDTA Tube (DNA will be amplified in order to preserve quantity) 1. x 10ml Lithium Heparin Tube (drawn on selected patient populations at CCF only- See Appendix E. for cell line protocol) 2. x 5 mls Serum Tube 1 x 7 mls Serum Tube 1 x 2.7 mls Sodium Citrate Tube (CCF Only. See Appendix D) 1 x 4.5 mls CTAD tube (platelet release inhibited) 1 x 4.5 mls SCAT-1 tube (coagulation activation inhibited) (Blood may be dispensed in the above tubes in different quantities if functional studies are needed on a subset of samples)

MeSH Terms

Conditions

Cardiovascular Diseases; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Stanley Hazen, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Head, Preventive Cardiology & Rehabilitation; Chair, Department of Cardiovascular and Metabolic Sciences; Director, Center for Microbiome & Human Health

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: January 1, 2001
• Primary Completion: July 1, 2007
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share