The Association of Platelet Function and Endothelial Function of the Brachial Artery
|ClinicalTrials.gov Identifier: NCT00363818|
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : April 11, 2008
|Condition or disease|
|Coronary Artery Disease Endothelial Function Thrombosis|
Background: Previous studies have shown a significant association between endothelial dysfunction and CAD and cardiovascular risk factors. Since the endothelium is a systemic organ, endothelial dysfunction is a systemic vascular disorder which bring about a reduction in nitric oxide (NO) bioavailability accounting for distraction of the platelet function. Thus, we expect to find an association between platelet function and endothelial function assessed by the brachial artery FMD in healthy subjects and in CAD patients. Moreover, as platelet function, normally blocked by an effective anti-thrombotic therapy, is linked to the progression of atherosclerosis which, by itself is an influential process on endothelial function, we expect to find an association between endothelial function and the success of anti-thrombotic therapy.
Aim: To determine the association between platelet function and endothelial function assessed by brachial artery FMD in healthy subjects and in CAD patients, and to determine the association between anti-thrombotic therapy and endothelial function.
Methods: The proposed study is a prospective one, and will be held on consecutive individuals undergoing the non-invasive brachial artery flow-mediated dilation (FMD) ultrasound for endothelial function at the endothelial function laboratory of the Sheba Medical Center. The study group will be divided into healthy subjects group and coronary artery disease (CAD) patients group, both of which will be analyzed in respect to age, cardiovascular risk factors and the results of the platelet and endothelial functions tests. The association between platelet and endothelial functions will be then assessed in the healthy subjects group and in the CAD patients group.
The assessment of endothelial function is relatively simple and non-invasive method of short duration. Implementing this simple method to comprehend the platelet function will enable clinicians to better monitor and control the platelet inhibition in healthy subjects (for primary prevention) and in CAD patients (for secondary prevention). In addition, the FMD method can be useful in the evaluation of the success of the (antithrombocytic) treatment, the prognosis and the risk-stratification in hospitalized patients with acute coronary syndromes.
|Study Type :||Observational|
|Actual Enrollment :||151 participants|
|Official Title:||The Association Between Platelet Function and Endothelial Function of the Brachial Artery in Healthy Subjects and in Patients With Coronary Artery Disease|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||March 2008|
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): NCT00363818
|Heart Center, Sheba Medical Center|
|Tel Hashomer, Israel, 52621|
|The Heart Institute, Sheba Medical Center|
|Tel Hashomer, Israel, 52621|
|Principal Investigator:||Michael Shechter, MD, MA||Sheba Medical Center|
|Principal Investigator:||Shlomi Matetzky, MD||Sheba Medical Center|