Natural History of Carotid Atherosclerosis

September 4, 2019 updated by: Konstantinos Toutouzas, National and Kapodistrian University of Athens

A Prospective Natural History Study of Carotid Atherosclerosis

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 11528
        • Recruiting
        • First Department of Cardiology, University of Athens, Medical School. Hippocratio Hospital
        • Contact:
        • Sub-Investigator:
          • Andreas Synetos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with coronary artery disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Time Frame
Relation of other demographic factors with carotid ultrasound and microwave radiometry measurements and outcome
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

January 25, 2012

First Submitted That Met QC Criteria

January 27, 2012

First Posted (Estimate)

January 30, 2012

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 4, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRcar

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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