Varying Characteristics of Atherogenesis and Cardiopulmonary Bypass Inflammatory Response - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Collaborator:	Brigham and Women's Hospital
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00281164

Purpose

The purpose of this study is to identify possible correlations between phenotypic variation in genes determining atherosclerotic cardiovascular disease (ASCVD), coagulation, and fibrinolysis genetic and plasma markers of chronic inflammation and hypercoagulability with the severity and extent of atherosclerosis, the inflammatory response to cardiac surgery in patients with ASCVD, and their effect on perioperative adverse outcomes.

Condition
Atherosclerosis Cardiovascular Diseases Heart Diseases Inflammation Blood Coagulation Disorders

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Phenotypic Variation in Atherogenesis and the Inflammatory Response to Cardiopulmonary Bypass

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Atherosclerosis Bleeding Disorders Heart Diseases

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Genetic factors that may influence the development of ASCVD [ Time Frame: Measured during hospitalization ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

DNA, RNA, citrated and EDTA plasma, serum at seven perioperative time points

Estimated Enrollment:	3000
Study Start Date:	July 2001
Estimated Study Completion Date:	December 2012

Show Detailed Description

Eligibility

Ages Eligible for Study:	20 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients undergoing coronary artery bypass surgery utilizing cardiopulmonary bypass

Criteria

Inclusion Criteria:

Undergoing cardiac surgery at Brigham and Women's Hospital

Exclusion Criteria:

Cannot or will not provide informed consent
Blood transfusion in the 30 days prior to study entry
Preoperative hematocrit less than 25%
Unlikely to complete long-term follow-up for non-cardiac medical reasons or for social reasons

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281164

Locations

United States, Massachusetts
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Dr. Simon C. Body, MD, MPH 617-732-8217 body@zeus.bwh.harvard.edu
Principal Investigator: Dr. Simon C. Body

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Brigham and Women's Hospital

Investigators

Study Chair:

Dr. Simon C. Body, MD, MPH

Brigham and Women's Hospital

More Information

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Muehlschlegel JD, Liu KY, Perry TE, Fox AA, Collard CD, Shernan SK, Body SC; CABG Genomics Investigators. Chromosome 9p21 variant predicts mortality after coronary artery bypass graft surgery. Circulation. 2010 Sep 14;122(11 Suppl):S60-5.

Muehlschlegel JD, Perry TE, Liu KY, Fox AA, Collard CD, Shernan SK, Body SC. Heart-type fatty acid binding protein is an independent predictor of death and ventricular dysfunction after coronary artery bypass graft surgery. Anesth Analg. 2010 Nov;111(5):1101-9. Epub 2010 May 10.

Body SC, Collard CD, Shernan SK, Fox AA, Liu KY, Ritchie MD, Perry TE, Muehlschlegel JD, Aranki S, Donahue BS, Pretorius M, Estrada JC, Ellinor PT, Newton-Cheh C, Seidman CE, Seidman JG, Herman DS, Lichtner P, Meitinger T, Pfeufer A, Kääb S, Brown NJ, Roden DM, Darbar D. Variation in the 4q25 chromosomal locus predicts atrial fibrillation after coronary artery bypass graft surgery. Circ Cardiovasc Genet. 2009 Oct;2(5):499-506. Epub 2009 Aug 2.

Garvin S, Muehlschlegel JD, Perry TE, Chen J, Liu KY, Fox AA, Collard CD, Aranki SF, Shernan SK, Body SC. Postoperative activity, but not preoperative activity, of antithrombin is associated with major adverse cardiac events after coronary artery bypass graft surgery. Anesth Analg. 2010 Oct;111(4):862-9. Epub 2009 Oct 9.

Responsible Party:	Dr. Jane Scott, National Heart, Blood, and Lung Institute, NIH
ClinicalTrials.gov Identifier:	NCT00281164 History of Changes
Other Study ID Numbers:	1323, K23 HL68774
Study First Received:	January 20, 2006
Last Updated:	July 10, 2009
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Atherosclerosis
Blood Coagulation Disorders
Hemostatic Disorders
Cardiovascular Diseases
Heart Diseases
Inflammation

Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012