GeneBank at the Cleveland Clinic: Molecular Determinants of Coronary Artery Disease - Full Text View

Sponsors and Collaborators:	The Cleveland Clinic National Institutes of Health (NIH) Millennium Pharmaceuticals, Inc.
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00590200

Purpose

This proposal delineates a research plan to collect blood from the patients undergoing heart catheterization or have had a heart catheterization within one year, coming in for outpatient appointments, or have scheduled cardiac CT scans at the Cleveland Clinic over a five-year period for the purpose of establishing a gene bank registry. The University of North Carolina at Chapel Hill will enroll 1,000 non-Caucasian patients. 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.

Condition
Cardiovascular Diseases

MedlinePlus related topics: Coronary Artery Disease Heart Attack

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Molecular Determinants of Coronary Artery Disease

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

Coronary Artery Disease [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Death [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Revascularization [ Time Frame: 3 years ] [ Designated as safety issue: No ]
PCI/Stent [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Myocardial Infarction [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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)

x 10ml Lithium Heparin Tube (drawn on selected patient populations at CCF only- See Appendix E. for cell line protocol)
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)

Estimated Enrollment:	15000
Study Start Date:	March 2001
Estimated Study Completion Date:	December 2009

Detailed Description:

The study is to commence on March 1st 2001 and is to be completed within 2-5 years. The targeted number of patients to be enrolled is 15,000. All 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. Patients inclusion criteria are as follows, once informed consent is obtained:

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)
All Patients undergoing Cardiac CT or had Cardiac CT within 1 year (CCF only) (Cleveland Clinic will follow inclusion criteria 1-7, 9, UNC and MetroHealth Medical Center will follow criteria1-8)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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.

Criteria

Inclusion Criteria:

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)
All Patients undergoing Cardiac CT or had Cardiac CT within 1 year (CCF only) (Cleveland Clinic will follow inclusion criteria 1-7, 9, UNC and MetroHealth Medical Center will follow criteria1-8)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590200

Sponsors and Collaborators

The Cleveland Clinic

National Institutes of Health (NIH)

Millennium Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Stanley Hazen, MD, PhD

Cleveland Clinic

More Information

No publications provided

Responsible Party:	Cleveland Clinic ( Stanley Hazen, MD, PhD )
Study ID Numbers:	1 P50 HL077107-03, IRB4265, GeneBank, 1 P50 HL077107-03, GATC
Study First Received:	December 26, 2007
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00590200 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by The Cleveland Clinic:

CAD
Cardiovascular Disease
CVD
MI
Myocardial Infarction

Heart Attack
CABG
Revascularization
genetic

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Arteriosclerosis
Ischemia
Infarction
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009