Clinical trial NCT01521351: Natural History of Carotid Atherosclerosis
Official title: A Prospective Natural History Study of Carotid Atherosclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Artery Disease
Stroke
Myocardial Infarction
Angina Pectoris
Keywords: microwave radiometry
cardiovascular events
carotid artery disease
stroke
myocardial infarction
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2012-01-30
Enrollment: 700
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease

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: Carotid artery Thermal heterogeneity recorded by MR will be corelated to cardiovascular events (death, cardiac events, cerebrovascular events) as well as to all demographic (age, sex, hypertension, dyslipidemia, smoking status, etc) factors

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 3 years
Secondary outcomes:
measure: Relation of other demographic factors with carotid ultrasound and microwave radiometry measurements and outcome
timeFrame: 3 years
Other outcomes:
Locations:
city: Athens
country: Greece
facility: First Department of Cardiology, University of Athens, Medical School. Hippocratio Hospital
state: Attiki
Study officials:
affiliation: First department of Cardiology, University of Athens Greece
name: Konstantinos Toutouzas
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
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.
citation: 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.
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.
citation: Toutouzas K, Benetos G, Oikonomou G, Barampoutis N, Koutagiar I, Galanakos S, Karmpalioti M, Drakopoulou M, Stathogiannis K, Bounas P, Gata V, Antoniadou F, Davlouros P, Alexopoulos D, Hahalis G, Siores E, Sfikakis PP, Tousoulis D. Increase in Carotid Temperature Heterogeneity Is Associated With Cardiovascular and Cerebrovascular Events. Circ Cardiovasc Imaging. 2018 Nov;11(11):e008292. doi: 10.1161/CIRCIMAGING.118.008292. No abstract available.