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

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

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.

Study Overview

• Status: Completed
• Conditions: Genetic Polymorphism

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.

• Study Type: Observational
• Enrollment (Anticipated): 475

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
genetic determination of bleeding verses thrombotic risk factors in patients undergoing cardiovascular procedures

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Samuel A. Santoro, MD, PhD, Vanderbilt University

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: October 17, 2007
• First Submitted That Met QC Criteria: January 26, 2008
• First Posted (Estimate): January 28, 2008

Study Record Updates

• Last Update Posted (Estimate): December 17, 2013
• Last Update Submitted That Met QC Criteria: December 16, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Phenotype; Genetic Polymorphism; Integrin alpha2beta1
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 060433