Expression of Angiogenic Factors in Myocardial Tissue
IRB #14547: Expression of Angiogenic Factors in Myocardial Tissue in Diabetic and Non-diabetic Patients Undergoing Coronary Bypass Surgery
1 other identifier
observational
60
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedMarch 8, 2016
March 1, 2016
1.9 years
September 17, 2010
March 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
tissue levels of HIF-1, VEGF and angiostatin
The investigators will evaluate tissue levels of HIF-1, VEGF and angiostatin in diabetic and non-diabetic patients coming for on-pump CABG.
initiation of CPB/ day 1
Study Arms (1)
CABG patients
atrial tissue samples from CABG patients
Interventions
Eligibility Criteria
diabetic \& non-diabetic CABG patients
You may qualify if:
- on-pump CABG
- years of age \& older
- informed consent
You may not qualify if:
- active malignancy
- severe lung disease (requiring home O2 therapy)
- severe anemia\<8g/dl
- patient with moderate or severe renal dysfunction
- off- pump CABG
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Related Publications (7)
Aguilar D, Solomon SD, Kober L, Rouleau JL, Skali H, McMurray JJ, Francis GS, Henis M, O'Connor CM, Diaz R, Belenkov YN, Varshavsky S, Leimberger JD, Velazquez EJ, Califf RM, Pfeffer MA. Newly diagnosed and previously known diabetes mellitus and 1-year outcomes of acute myocardial infarction: the VALsartan In Acute myocardial iNfarcTion (VALIANT) trial. Circulation. 2004 Sep 21;110(12):1572-8. doi: 10.1161/01.CIR.0000142047.28024.F2. Epub 2004 Sep 13.
PMID: 15364810BACKGROUNDZairis MN, Lyras AG, Makrygiannis SS, Psarogianni PK, Adamopoulou EN, Handanis SM, Papantonakos A, Argyrakis SK, Prekates AA, Foussas SG. Type 2 diabetes and intravenous thrombolysis outcome in the setting of ST elevation myocardial infarction. Diabetes Care. 2004 Apr;27(4):967-71. doi: 10.2337/diacare.27.4.967.
PMID: 15047657BACKGROUNDDonahoe SM, Stewart GC, McCabe CH, Mohanavelu S, Murphy SA, Cannon CP, Antman EM. Diabetes and mortality following acute coronary syndromes. JAMA. 2007 Aug 15;298(7):765-75. doi: 10.1001/jama.298.7.765.
PMID: 17699010BACKGROUNDAbbott RD, Donahue RP, Kannel WB, Wilson PW. The impact of diabetes on survival following myocardial infarction in men vs women. The Framingham Study. JAMA. 1988 Dec 16;260(23):3456-60.
PMID: 2974889BACKGROUNDSemenza GL. Hypoxia-inducible factor 1 and the molecular physiology of oxygen homeostasis. J Lab Clin Med. 1998 Mar;131(3):207-14. doi: 10.1016/s0022-2143(98)90091-9. No abstract available.
PMID: 9523843BACKGROUNDSemenza GL, Roth PH, Fang HM, Wang GL. Transcriptional regulation of genes encoding glycolytic enzymes by hypoxia-inducible factor 1. J Biol Chem. 1994 Sep 23;269(38):23757-63.
PMID: 8089148BACKGROUNDWeihrauch D, Lohr NL, Mraovic B, Ludwig LM, Chilian WM, Pagel PS, Warltier DC, Kersten JR. Chronic hyperglycemia attenuates coronary collateral development and impairs proliferative properties of myocardial interstitial fluid by production of angiostatin. Circulation. 2004 May 18;109(19):2343-8. doi: 10.1161/01.CIR.0000129225.67353.1F. Epub 2004 May 10.
PMID: 15136506BACKGROUND
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob Raphael, MD
UVA Anesthesiology
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Anesthesiologist
Study Record Dates
First Submitted
September 17, 2010
First Posted
August 11, 2011
Study Start
August 1, 2009
Primary Completion
July 1, 2011
Study Completion
August 1, 2011
Last Updated
March 8, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share