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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50HL077107-02 | U.S. NIH Grant/Contract | View source | |
| IRB 4265 | Other Identifier | Institutional Review Board | |
| GeneBank | Other Identifier | Cleveland Clinic Foundation |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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:
(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.
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| Measure | Description | Time Frame |
|---|---|---|
| Coronary Artery Disease | Development of Coronary Artery Disease | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Death | All cause mortality | 5 years |
| Revascularization | Need for revascularization | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
None except as noted in the inclusion criteria
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Stanley Hazen, MD, PhD | The Cleveland Clinic | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38124458 | Derived | Tang WHW, Nemet I, Li XS, Wu Y, Haghikia A, Witkowski M, Koeth RA, Demuth I, Konig M, Steinhagen-Thiessen E, Backhed F, Fischbach MA, Deb A, Landmesser U, Hazen SL. Prognostic value of gut microbe-generated metabolite phenylacetylglutamine in patients with heart failure. Eur J Heart Fail. 2024 Feb;26(2):233-241. doi: 10.1002/ejhf.3111. Epub 2024 Jan 25. | |
| 34419046 | Derived | 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. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
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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 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)
| Percutaneous Coronary Intervention/Stent | Need for percutaneous coronary intervention and/or stent | 3 years |
| Myocardial Infarction | New myocardial infarction | 3 years |
| 22899766 | 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. |
| D007511 |
| Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |