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The Association of Platelet Function and Endothelial Function of the Brachial Artery

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00363818
First received: August 11, 2006
Last updated: April 8, 2008
Last verified: April 2008
  Purpose

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
Coronary Artery Disease
Endothelial Function
Thrombosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

Further study details as provided by Sheba Medical Center:

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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients will be recruited from the Heart Institute Coronary care Unit and outpatient clinic

Criteria

Inclusion Criteria:

  • Healthy subjects (i.e., subjects without any history of chest pain or myocardial infarction, coronary artery bypass grafting surgery, coronary angiography with angioplasty and/or stenting, cerebrovascular accident, or peripheral vascular disease) with normal electrocardiograms and echocardiography on admission, and patients with coronary artery disease(i.e, patients with history of myocardial infarction, coronary artery bypass grafting operation, coronary angiography with angioplasty or stenting, heart failure secondary to coronary artery disease, or cerebrovascular accident).

Exclusion Criteria:

  • Exclusion criteria included atrial fibrillation, sinus bradycardia (heart rate < 50 bpm) without pacemaker, sick sinus syndrome, second or third degree AV block, intolerance to nitrates, renal failure with serum creatinine > 3 mg/dl, history of drug or alcohol abuse, chronic liver disease, or refusal to sign the informed consent form.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363818

Locations
Israel
Heart Center, Sheba Medical Center
Tel Hashomer, Israel, 52621
The Heart Institute, Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Michael Shechter, MD, MA Sheba Medical Center
Principal Investigator: Shlomi Matetzky, MD Sheba Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Shechter, MD, Shlomi Matetzky, MD, PIs, Heart Institute, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00363818     History of Changes
Other Study ID Numbers: SHEBA-05-3919-MS-CTIL
Study First Received: August 11, 2006
Last Updated: April 8, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Endothelial function
Platelet function
Coronary artery disease
Thrombosis
Aggregation

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Thrombosis
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Embolism and Thrombosis
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014