Varying Characteristics of Atherogenesis and Cardiopulmonary Bypass Inflammatory Response

This study is currently recruiting participants.

Verified by National Heart, Lung, and Blood Institute (NHLBI), July 2009

First Received: January 20, 2006 Last Updated: July 10, 2009 History of Changes

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:	Cohort, 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: 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

Biospecimen Description:

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 National Clinical Trials Identifier (NCT ID):

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.

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

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Atherosclerosis
Pathologic Processes
Hemorrhagic Disorders
Heart Diseases
Hematologic Diseases

Blood Coagulation Disorders
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Hemostatic Disorders
Inflammation

ClinicalTrials.gov processed this record on February 08, 2010