Natural History of Carotid Atherosclerosis

This study is currently recruiting participants.

Verified January 2012 by University of Athens

Sponsor:

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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 25, 2012
Last Updated Date	January 27, 2012
Start Date ^ICMJE	January 2012
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 27, 2012)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01521351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 27, 2012)	Relation of other demographic factors with carotid ultrasound and microwave radiometry measurements and outcome [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Natural History of Carotid Atherosclerosis
Official Title ^ICMJE	A Prospective Natural History Study of Carotid Atherosclerosis
Brief Summary	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
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients with coronary artery disease
Condition ^ICMJE	Carotid Artery Disease Stroke Myocardial Infarction Angina Pectoris
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	carotid thermal heterogeneity no carotid thermal heterogeneity carotid artery disease no carotid artery disease
Publications *	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. Epub 2010 Dec 23. No abstract available.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	700
Estimated Completion Date	December 2015
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	30 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Greece

Administrative Information
NCT Number ^ICMJE	NCT01521351
Other Study ID Numbers ^ICMJE	MRcar
Has Data Monitoring Committee	No
Responsible Party	Konstantinos Toutouzas, University of Athens
Study Sponsor ^ICMJE	University of Athens
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Athens
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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