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Sponsors and Collaborators: |
Vanderbilt University National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00603148 |
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 |
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Genetic Polymorphism |
Study Type: | Observational |
Study Design: | Cohort, 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 |
Whole Blood
Estimated Enrollment: | 475 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | September 2008 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
patients undergoing procedures in a hybrid interventional cardiology/cardiac surgery suite
Inclusion Criteria:
Contact: Samuel Santoro, MD, PhD | 615-322-3234 | samuel.a.santoro@vanderbilt.edu |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Samuel A. Santoro, MD, PhD 615-322-3234 samuel.a.santoro@vanderbilt.edu | |
Sub-Investigator: David Zhao, MD, PhD | |
Sub-Investigator: Scott M Williams, PhD |
Principal Investigator: | Samuel A. Santoro, MD, PhD | Vanderbilt University |
Study ID Numbers: | 060433 |
Study First Received: | October 17, 2007 |
Last Updated: | January 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00603148 |
Health Authority: | United States: Institutional Review Board |
Genetic Polymorphism Integrin alpha2beta1 Phenotype |
Hemorrhage |