Natural History of Carotid Atherosclerosis

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Arteriosclerosis
Atherosclerosis
Carotid Artery Diseases
Infarction
Myocardial Infarction
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Chest Pain
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Nervous System Diseases
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014