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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00603148
First Posted: January 28, 2008
Last Update Posted: December 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Samuel A. Santoro, Vanderbilt University
  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 Samuel A. Santoro, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00603148


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Samuel A. Santoro, MD, PhD Vanderbilt University
  More Information

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
First Submitted: October 17, 2007
First Posted: January 28, 2008
Last Update Posted: December 17, 2013
Last Verified: December 2013

Keywords provided by Samuel A. Santoro, Vanderbilt University:
Genetic Polymorphism
Integrin alpha2beta1
Phenotype