Viewing Study NCT00363818



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Study NCT ID: NCT00363818
Status: COMPLETED
Last Update Posted: 2008-04-11
First Post: 2006-08-11

Brief Title: The Association of Platelet Function and Endothelial Function of the Brachial Artery
Sponsor: Sheba Medical Center
Organization: Sheba Medical Center

Study Overview

Official Title: The Association Between Platelet Function and Endothelial Function of the Brachial Artery in Healthy Subjects and in Patients With Coronary Artery Disease
Status: COMPLETED
Status Verified Date: 2008-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None