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

 1. Males or females at least 18 years old.

 2. Patient has not been previously enrolled in the genebank registry.

 3. Patient able to give informed consent.

 4. 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.

 5. 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 Coronary Artery Disease (CAD), the subject's blood and data will still be
 useful in the Genebank under the broader scope of the study)

 6. Any patient with history of myocardial infarction (MI). (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.)

 7. Non-caucasian patients or of Hispanic Ethnicity (UNC and MetroHealth Medical Center
 only)

 8. All Patients undergoing Cardiac CT or had Cardiac CT within 1 year (CCF only)

 9. Any patient coming to the Heart and Vascular Institute for outpatient scheduled
 appointments.

 10. Any patients that have had or are going to have an implanted cardioverter defibrillator
 (ICD) or cardiac resynchronization defibrillator (CRT-D).

 11. Any patients with cardiac arrhythmias or a family history of cardiac arrhythmias.

 (Cleveland Clinic will follow inclusion criteria 1-6 and 8-11, UNC and MetroHealth Medical
 Center will follow criteria 1-11).

 Exclusion criteria:

 None except as in Inclusion criteria.
Inclusion Criteria:

 1. Males or females at least 18 years old.

 2. Patient has not been previously enrolled in the genebank registry.

 3. Patient able to give informed consent.

 4. 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.

 5. 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).

 6. 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).

 7. Non-caucasian patients or of Hispanic Ethnicity (UNC and MetroHealth Medical; Center
 only).

 8. 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).

 9. Any patients coming to the Heart and Vascular Institute for outpatient scheduled
 appointments.

 10. Any patients that have had or are going to have an implanted cardioverter
 defibrillator (ICD) or Cardiac Resynchronization Defibrillator (CRT-D).

 11. Any patients with cardiac arrhythmias or a family history of cardiac arrhythmias.

 Exclusion Criteria:

 None except as noted in the inclusion criteria