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| Sponsor: | Lavi Cardiatec |
|---|---|
| Information provided by: | Lavi Cardiatec |
| ClinicalTrials.gov Identifier: | NCT00650741 |
Purpose
The purpose of the study is to investigate the sensitivity and specificity of the Endotect compared with an ultrasound device in a flow-mediated vasodilatation (FMD) test.
| Condition |
|---|
|
Endothelial Dysfunction |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | Evaluation of a New Non-Invasive Device for Detection of Endothelial Dysfunction |
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2008 |
| Groups/Cohorts |
|---|
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1
10 subjects, Half with Endothelial Dysfucntion (according to previous ultrasound FMD) , Half with no endothelial dysfucntion (according to previous ultrasound FMD), no repetition of test
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|
2
10 subjects, Half with Endothelial Dysfucntion (according to previous ultrasound FMD) , Half with no endothelial dysfucntion (according to previous ultrasound FMD), Repetition with Nitroglycerin
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|
3
10 subjects, Half with Endothelial Dysfucntion (according to previous ultrasound FMD) , Half with no endothelial dysfucntion (according to previous ultrasound FMD), repetition of test with the Endotect
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The study compares the results obtained with Endotect with the results obtained from a brachial ultrasound FMD test, with and without nitroglycerin.
The results from 3 patient groups (see below) will be compared
1: 10 subjects, Half with Endothelial Dysfucntion (according to previous ultrasound FMD) , Half with no endothelial dysfucntion (according to previous ultrasound FMD), no repetition of test 2: 10 subjects, Half with Endothelial Dysfucntion (according to previous ultrasound FMD) , Half with no endothelial dysfucntion (according to previous ultrasound FMD), Repetition with Nitroglycerin 3: 10 subjects, Half with Endothelial Dysfucntion (according to previous ultrasound FMD) , Half with no endothelial dysfucntion (according to previous ultrasound FMD), repetition of test with the Endotect
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients who visited a clinic where FMD is performed and community sample
Inclusion Criteria:
Exclusion Criteria:
Any of the following:
Contacts and Locations| Israel | |
| Sheba Medical Center, Heart Institutue | |
| Tel Hashomer, Israel | |
| Study Director: | Giora Amitzur, Ph. D. | Heart Institute, Sheba Medical Center and Tel Aviv University, Israel |
| Principal Investigator: | Michael Schechter, MD MA FACC | Heart Institute, Sheba Medical Center, Israel |
More Information
| Responsible Party: | Avner Amir CEO, Lavi Cardiatec |
| ClinicalTrials.gov Identifier: | NCT00650741 History of Changes |
| Other Study ID Numbers: | SMC0001 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 30, 2008 |
| Health Authority: | Israel: Ministry of Health |
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Endothelial Dysfunction FMD |