The Association of Platelet Function and Endothelial Function of the Brachial Artery
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| First Received Date ICMJE | August 11, 2006 | ||||||||
| Last Updated Date | April 8, 2008 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00363818 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Association of Platelet Function and Endothelial Function of the Brachial Artery | ||||||||
| Official Title ICMJE | The Association Between Platelet Function and Endothelial Function of the Brachial Artery in Healthy Subjects and in Patients With Coronary Artery Disease | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients will be recruited from the Heart Institute Coronary care Unit and outpatient clinic |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 151 | ||||||||
| Completion Date | March 2008 | ||||||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00363818 | ||||||||
| Other Study ID Numbers ICMJE | SHEBA-05-3919-MS-CTIL | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Michael Shechter, MD, Shlomi Matetzky, MD, PIs, Heart Institute, Sheba Medical Center | ||||||||
| Study Sponsor ICMJE | Sheba Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Sheba Medical Center | ||||||||
| Verification Date | April 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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