The Role of Platelet Surface α2β1 Integrin Expression as a Risk Factor in Thrombotic and/or Bleeding Complications

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Samuel A. Santoro, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00603148
First received: October 17, 2007
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

This study will begin to define these critical determinants for patients undergoing procedures in the hybrid interventional cardiology/cardiac surgery suite. In future studies, the data obtained from this study will be used to prospectively stratify patients in terms of bleeding verses thrombotic risk to design studies to optimize anticoagulation and anti-platelet therapies in the hybrid setting.


Condition
Genetic Polymorphism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Platelet Surface α2β1 Integrin Expression as a Risk Factor in Thrombotic and/or Bleeding Complications in Patients Undergoing Invasive Procedures in the Hybrid Cardiac Catheterization/Cardiac Surgery Suite

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • genetic determination of bleeding verses thrombotic risk factors in patients undergoing cardiovascular procedures

Biospecimen Retention:   Samples With DNA

Whole Blood


Estimated Enrollment: 475
Study Start Date: September 2006
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Detailed Description:

The aim of this study is to test the association of DNA polymorphisms linked to the level of αβ1 integrin expression on platelets with clinical outcome in terms of bleeding or thrombotic complications. The association of polymorphisms in other genes such as GPVI, PAR-1, and COX-2, as well as PLA ½ status, will also be examined and considered in the context of other factors such as medications including IIb/IIIa inhibitors, anticoagulants, type of procedure, obesity smoking status, etc.

Lower levels of platelet surface expression of the α2β1 integrin are associated with an increased risk of bleeding complications following hybrid procedures, especially when the low level of integrin expression is associated with other risk factors that may exacerbate bleeding such as vigorous anti-coagulation, aggressive anti-platelet therapy and other genetic risk factors that contribute to a hemorrhagic phenotype. Conversely, higher level expression of the α2β1 integrin is likely associated with a greater tendency to thrombotic complication that is again modified by other coexisting risk factors.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients undergoing procedures in a hybrid interventional cardiology/cardiac surgery suite

Criteria

Inclusion Criteria:

  • Patients will be recruited to the study who are to undergo elective hybrid procedures [percutaneous coronary intervention (PCI) followed by minimally invasive coronary artery bypass graft (CABG) surgery or valve surgery].
  • Both male and females will be enrolled in this study.
  • The age of the population is 18-70 years old.
  • No one ethnic group or gender will be targeted or excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603148

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Samuel A. Santoro, MD, PhD Vanderbilt University
  More Information

No publications provided

Responsible Party: Samuel A. Santoro, Professor and Chair, Pathology, Microbiology & Immunology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00603148     History of Changes
Other Study ID Numbers: 060433
Study First Received: October 17, 2007
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Genetic Polymorphism
Integrin alpha2beta1
Phenotype

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014