Stroke Clinical Trial
Official title:
A Prospective Natural History Study of Carotid Atherosclerosis
| NCT number | NCT01521351 |
| Other study ID # | MRcar |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2012 |
| Est. completion date | December 2020 |
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
| Status | Recruiting |
| Enrollment | 700 |
| Est. completion date | December 2020 |
| Est. primary completion date | June 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Greece | First Department of Cardiology, University of Athens, Medical School. Hippocratio Hospital | Athens | Attiki |
| Lead Sponsor | Collaborator |
|---|---|
| National and Kapodistrian University of Athens |
Greece,
Toutouzas K, Benetos G, Drakopoulou M, Bounas P, Tsekoura D, Stathogiannis K, Koutagiar I, Aggeli C, Karanasos A, Panagiotakos D, Siores E, Stefanadis C. Insights from a thermography-based method suggesting higher carotid inflammation in patients with diabetes mellitus and coronary artery disease. Diabetes Metab. 2014 Dec;40(6):431-8. doi: 10.1016/j.diabet.2014.05.005. Epub 2014 Jun 26. — View Citation
Toutouzas K, Benetos G, Drakopoulou M, Deligianni C, Spengos K, Stefanadis C, Siores E, Tousoulis D. Incremental predictive value of carotid inflammation in acute ischemic stroke. Stroke. 2015 Jan;46(1):272-4. doi: 10.1161/STROKEAHA.114.007526. Epub 2014 Nov 4. — View Citation
Toutouzas K, Benetos G, Drakopoulou M, Michelongona A, Nikolaou C, Masoura C, Stathogiannis K, Aggeli C, Tsiamis E, Siores E, Stefanadis C. Morphological and functional assessment of carotid plaques have similar predictive accuracy for coronary artery disease. Stroke. 2013 Sep;44(9):2607-9. doi: 10.1161/STROKEAHA.113.002462. Epub 2013 Jul 25. — View Citation
Toutouzas K, Grassos H, Synetos A, Drakopoulou M, Tsiamis E, Moldovan C, Agrogiannis G, Patsouris E, Siores E, Stefanadis C. A new non-invasive method for detection of local inflammation in atherosclerotic plaques: experimental application of microwave radiometry. Atherosclerosis. 2011 Mar;215(1):82-9. doi: 10.1016/j.atherosclerosis.2010.12.019. Epub 2010 Dec 23. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | 3 years | |
| Secondary | Relation of other demographic factors with carotid ultrasound and microwave radiometry measurements and outcome | 3 years |
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