Expression of Angiogenic Factors in Myocardial Tissue in Diabetic and Non-diabetic Patients Undergoing Coronary Bypass Surgery
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Purpose
The purpose of this study is to evaluate whether angiogenesis is decreased in diabetic patients with coronary artery disease compared to non-diabetics with coronary artery disease. The protein expression of angiogenic factors will be examined in atrial tissue prior to initiation of cardiopulmonary bypass in patients undergoing coronary bypass surgery.
The goal of this project is to evaluate the tissue levels of HIF-1, VEGF and angiostatin in diabetic and non-diabetic patients coming for on-pump coronary artery bypass graft (CABG).
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease |
Other: atrial tissue sample form diabetic CABG patient Other: atrial tissue sample from non-diabetic CABG patient |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | IRB #14547: Expression of Angiogenic Factors in Myocardial Tissue in Diabetic and Non-diabetic Patients Undergoing Coronary Bypass Surgery |
- tissue levels of HIF-1, VEGF and angiostatin [ Time Frame: initiation of CPB/ day 1 ] [ Designated as safety issue: No ]The investigators will evaluate tissue levels of HIF-1, VEGF and angiostatin in diabetic and non-diabetic patients coming for on-pump CABG.
Biospecimen Retention: Samples With DNA
During the cannulation process before the initiation of CPB(cardiopulmonary bypass) a small piece of right atrial tissue is cut in order to insert venous drainage cannula to the right atrium. This small piece of tissue is discarded and is not sent for pathology.
| Enrollment: | 60 |
| Study Start Date: | August 2009 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
diabetic CABG patients
diabetic CABG patients
|
Other: atrial tissue sample form diabetic CABG patient
atrial tissue sample from diabetic CABG patient
|
|
non-diabetic CABG patient
non-diabetic CABG patient
|
Other: atrial tissue sample from non-diabetic CABG patient
atrial tissue sample from non-diabetic CABG patient
|
Detailed Description:
Coronary artery disease and its complications are the leading cause of death in the western world. Diabetes mellitus (DM) is one of the major risk factors to develop coronary artery disease, myocardial infarction and post-infarction complication1-3. Furthermore, mortality from myocardial infarction is almost doubled in diabetic patients compared to non-diabetics4. Despite significant amount of research, the basis for these differences in outcome still remains unclear. The survival of myocardial tissue subjected to ischemia can be increased by the ability to promote growth of new blood vessels into ischemic areas, thus limiting regions of impairment and ultimately preserving myocardial function. Hypoxia inducible factor (HIF) -1 is a transcription factor that promotes the expression of several genes that confer protection against hypoxia/ischemia through angiogenesis, erythropoiesis, vasodilation, and altered glucose metabolism5,6. Our hypothesis is that angiogenesis may be impaired in diabetes mainly via decreased protein expression and activation of HIF-1 and its main downstream target vascular endothelial growth factor (VEGF), as well as the inhibitor angiogenesis factor, angiostatin7, in the heart. Therefore the purpose of this study is to examine whether the angiogenic process during coronary ischemia is influenced by diabetes. To address these questions, HIF-1, VEGF and angiostatin protein expression will be evaluated in atrial tissue obtained from patients with and without diabetes who will undergo coronary bypass surgery. In addition comparison between emergency and elective procedure will be performed in regard to HIF-1 and VEGF protein levels and correlation with chronic statin therapy will be performed.
During the cannulation process, prior to initiation of cardiopulmonary bypass (CPB) during heart surgery, a small piece of the right atrium is cut in order to insert a venous cannula into that chamber. The investigators intend to use this piece of tissue (that is routinely wasted) in our protein and histological analyses.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
diabetic & non-diabetic CABG patients
Inclusion Criteria:
- on-pump CABG
- 18 years of age & older
- informed consent
Exclusion Criteria:
- active malignancy
- severe lung disease (requiring home O2 therapy)
- severe anemia<8g/dl
- patient with moderate or severe renal dysfunction
- off- pump CABG
Contacts and Locations| United States, Virginia | |
| University of Virginia Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| Principal Investigator: | Jacob Raphael, MD | UVA Anesthesiology |
More Information
Publications:
| Responsible Party: | Jacob Raphael MD, UVA Anesthesiology |
| ClinicalTrials.gov Identifier: | NCT01414621 History of Changes |
| Other Study ID Numbers: | 14547 |
| Study First Received: | September 17, 2010 |
| Last Updated: | August 10, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Virginia:
|
CABG |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Angiogenesis Inducing Agents Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013