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Sponsored by: |
Sheba Medical Center |
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Information provided by: | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00363818 |
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.
Condition |
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Coronary Artery Disease Endothelial Function Thrombosis |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | The Association Between Platelet Function and Endothelial Function of the Brachial Artery in Healthy Subjects and in Patients With Coronary Artery Disease |
Enrollment: | 151 |
Study Start Date: | January 2006 |
Study Completion Date: | March 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Patients will be recruited from the Heart Institute Coronary care Unit and outpatient clinic
Inclusion Criteria:
Exclusion Criteria:
Israel | |
The Heart Institute, Sheba Medical Center | |
Tel Hashomer, Israel, 52621 | |
Heart Center, Sheba Medical Center | |
Tel Hashomer, Israel, 52621 | |
Heart Center, Sheba Medical Center | |
Tel Hashomer, Israel, 52621 |
Principal Investigator: | Michael Shechter, MD, MA | Sheba Medical Center |
Principal Investigator: | Shlomi Matetzky, MD | Sheba Medical Center |
Responsible Party: | Heart Institute, Sheba Medical Center ( Michael Shechter, MD, Shlomi Matetzky, MD, PIs ) |
Study ID Numbers: | SHEBA-05-3919-MS-CTIL |
Study First Received: | August 11, 2006 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00363818 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Endothelial function Platelet function Coronary artery disease Thrombosis Aggregation |
Arterial Occlusive Diseases Coronary Disease Embolism and Thrombosis Heart Diseases Embolism Myocardial Ischemia |
Vascular Diseases Healthy Arteriosclerosis Ischemia Thrombosis Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Embolism and Thrombosis Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Thrombosis Coronary Artery Disease |