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Natural History of Carotid Atherosclerosis

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ClinicalTrials.gov Identifier: NCT01521351
Recruitment Status : Unknown
Verified May 2015 by Konstantinos Toutouzas, University of Athens.
Recruitment status was:  Recruiting
First Posted : January 30, 2012
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):

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
Carotid Artery Disease Stroke Myocardial Infarction Angina Pectoris

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
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Natural History Study of Carotid Atherosclerosis
Study Start Date : January 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


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 [ 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


Secondary Outcome Measures :
  1. Relation of other demographic factors with carotid ultrasound and microwave radiometry measurements and outcome [ Time Frame: 3 years ]

Eligibility Criteria

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521351


Contacts
Contact: Konstantinos Toutouzas ktoutouz@gmail.com
Contact: Andreas Synetos synetos@yahoo.com

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
Investigators
Principal Investigator: Konstantinos Toutouzas First department of Cardiology, University of Athens Greece
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
First Posted: January 30, 2012    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Konstantinos Toutouzas, University of Athens:
microwave radiometry
cardiovascular events
carotid artery disease
stroke
myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Atherosclerosis
Angina Pectoris
Carotid Artery Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases