Natural History of Carotid Atherosclerosis
This study is currently recruiting participants.
Verified January 2012 by University of Athens
Sponsor:
University of Athens
Information provided by (Responsible Party):
Konstantinos Toutouzas, University of Athens
ClinicalTrials.gov Identifier:
NCT01521351
First received: January 25, 2012
Last updated: January 27, 2012
Last verified: January 2012
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Purpose
A prospective study of 700 patients with coronary artery disease will undergo non invasive evaluation of their carotid arteries by ultrasound and microwave radiometry. The patients will be followed up for 3 years and their outcome regarding the cardiovascular events (death, cardiac events, cerebrovascular events) will be recorded
| Condition |
|---|
|
Carotid Artery Disease Stroke Myocardial Infarction Angina Pectoris |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective Natural History Study of Carotid Atherosclerosis |
Resource links provided by NLM:
MedlinePlus related topics:
Angina
Atherosclerosis
Carotid Artery Disease
Coronary Artery Disease
Heart Attack
U.S. FDA Resources
Further study details as provided by University of Athens:
Primary Outcome Measures:
- To detect if carotid ultrasound and carotid microwave radiometry measurements can predict the incidence of cerebrovascular and cardiovascular events in patients with coronary artery disease [ Time Frame: 3 years ] [ Designated as safety issue: No ]Microwave radiometry is a non invasive and safe technique that measures temperature of the internal tissues by detecting the normal radiation of the tissues in microwave frequencies. The primary outcome of the study is to see if the temperatures measured in the carotid arteries of patients with coronary artery disease can predict their outcome regarding cerebrovascular and cardiovascular events
Secondary Outcome Measures:
- Relation of other demographic factors with carotid ultrasound and microwave radiometry measurements and outcome [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 700 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| carotid thermal heterogeneity |
| no carotid thermal heterogeneity |
| carotid artery disease |
| no carotid artery disease |
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with coronary artery disease
Criteria
Inclusion Criteria:
- Consecutive patients with coronary artery disease admitted in our hospital
Exclusion Criteria:
- Patients with history of previous cerebrovascular event,
- History of vasculitis, intermittent inflammatory, infectious, or neoplastic conditions likely to be associated with an acute-phase response.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521351
Locations
| Greece | |
| First Department of Cardiology, University of Athens, Medical School. Hippocratio Hospital | Recruiting |
| Athens, Attiki, Greece, 11528 | |
| Contact: Andreas Synetos, MD 00306945417784 synetos@yahoo.com | |
| Sub-Investigator: Andreas Synetos, MD | |
Sponsors and Collaborators
University of Athens
More Information
Additional Information:
Publications:
| Responsible Party: | Konstantinos Toutouzas, Associate Professor of Cardiology, University of Athens |
| ClinicalTrials.gov Identifier: | NCT01521351 History of Changes |
| Other Study ID Numbers: | MRcar |
| Study First Received: | January 25, 2012 |
| Last Updated: | January 27, 2012 |
| Health Authority: | Greece: Ethics Committee |
Keywords provided by University of Athens:
|
microwave radiometry cardiovascular events carotid artery disease stroke myocardial infarction |
Additional relevant MeSH terms:
|
Angina Pectoris Atherosclerosis Carotid Artery Diseases Infarction Myocardial Infarction Stroke Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain |
Pain Signs and Symptoms Arteriosclerosis Arterial Occlusive Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Ischemia Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on June 18, 2013