Ignite Creation Date:
2024-05-05 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 9:40 AM
Study NCT ID:
NCT00590200
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2007-12-26
Brief Title:
GeneBank at the Cleveland Clinic Molecular Determinants of Coronary Artery Disease
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Molecular Determinants of Coronary Artery Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GATC
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 1000 non-Caucasian patients and MetroHealth Medical center in Cleveland will enroll 1000 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 ie 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
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 15000 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 yo 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 subjects 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 subjects 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
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 yo 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 subjects 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 subjects 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB 4265 | OTHER | None | None |
| GeneBank | OTHER | None | None |
| 1P50HL077107-03 | NIH | Cleveland Clinic Foundation | httpsreporternihgovquickSearch1P50HL077107-03 |