Expression of Angiogenic Factors in Myocardial Tissue in Diabetic and Non-diabetic Patients Undergoing Coronary Bypass Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT01414621
First received: September 17, 2010
Last updated: August 10, 2011
Last verified: August 2011
  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

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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
Study Population

diabetic & non-diabetic CABG patients

Criteria

Inclusion Criteria:

  1. on-pump CABG
  2. 18 years of age & older
  3. informed consent

Exclusion Criteria:

  1. active malignancy
  2. severe lung disease (requiring home O2 therapy)
  3. severe anemia<8g/dl
  4. patient with moderate or severe renal dysfunction
  5. off- pump CABG
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01414621

Locations
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
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 August 18, 2014