Natural History of Carotid Atherosclerosis

Sponsor
National and Kapodistrian University of Athens (Other)
Overall Status
Unknown status
CT.gov ID
NCT01521351
Collaborator
(none)
700
1
107
6.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    700 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Natural History Study of Carotid Atherosclerosis
    Study Start Date :
    Jan 1, 2012
    Anticipated Primary Completion Date :
    Jun 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    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 [3 years]

      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

    1. Relation of other demographic factors with carotid ultrasound and microwave radiometry measurements and outcome [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 First Department of Cardiology, University of Athens, Medical School. Hippocratio Hospital Athens Attiki Greece 11528

    Sponsors and Collaborators

    • National and Kapodistrian University of Athens

    Investigators

    • Principal Investigator: Konstantinos Toutouzas, First department of Cardiology, University of Athens Greece

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Konstantinos Toutouzas, Associate Professor of Cardiology, National and Kapodistrian University of Athens
    ClinicalTrials.gov Identifier:
    NCT01521351
    Other Study ID Numbers:
    • MRcar
    First Posted:
    Jan 30, 2012
    Last Update Posted:
    Sep 6, 2019
    Last Verified:
    Sep 1, 2019
    Keywords provided by Konstantinos Toutouzas, Associate Professor of Cardiology, National and Kapodistrian University of Athens
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 6, 2019