Natural History of Carotid Atherosclerosis

NCT01521351 | Unknown

• 1 other identifier: MRcar
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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

Conditions

Carotid Artery Disease; Stroke; Myocardial Infarction; Angina Pectoris

Keywords

microwave radiometry; cardiovascular events; carotid artery disease; stroke; myocardial infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Relation of other demographic factors with carotid ultrasound and microwave radiometry measurements and outcome

  3 years

Study Arms (4)

carotid thermal heterogeneity

Patients that have carotid thermal heterogeneity detected by MR

no carotid thermal heterogeneity

Patients that DONT have carotid thermal heterogeneity detected by MR

carotid artery disease

Patients with detected carotid artery disease by ultrasound

no carotid artery disease

Patients with no carotid artery disease detected by ultrasound

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary artery disease

You may qualify if:

• Consecutive patients with coronary artery disease admitted in our hospital

You may not qualify if:

• 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.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

First Department of Cardiology, University of Athens, Medical School. Hippocratio Hospital

Athens, Attica, 11528, Greece

RECRUITING

Related Publications (5)

• 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.

  PMID: 21256490 BACKGROUND

• 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.

  PMID: 25370590 BACKGROUND

• 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.

  PMID: 24981292 BACKGROUND

• 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.

  PMID: 23887842 BACKGROUND

• 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.

  PMID: 30571323 DERIVED

Related Links

• related info
• Ippocration Hospital
• University of Athens Medical School

MeSH Terms

Conditions

Carotid Artery Diseases; Stroke; Myocardial Infarction; Angina Pectoris

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Konstantinos Toutouzas

  First department of Cardiology, University of Athens Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantinos Toutouzas

CONTACT

ktoutouz@gmail.com

Andreas Synetos

CONTACT

synetos@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiology

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: January 30, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

GR (1)