Carotid Artery DiseaseNCT01521351
Natural History of Carotid Atherosclerosis
An observational study of Carotid Artery Disease and Stroke, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Carotid Artery Disease, Stroke, Myocardial Infarction
- How many people
- 700 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2012to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease
Who may be able to join
- Consecutive patients with coronary artery disease admitted in our hospital
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Konstantinos Toutouzas contact
Andreas Synetos contact
Greece1 site, 1 recruiting
- Recruiting
First Department of Cardiology, University of Athens, Medical School. Hippocratio Hospital
Athens, Attica, 11528
Andreas Synetos, MD, 00306945417784, synetos@yahoo.com
Andreas Synetos, MD
About this study
Official title: 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
Read the 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
- Conditions
- Carotid Artery Disease, Stroke, Myocardial Infarction, Angina Pectoris
- Keywords
- microwave radiometry, cardiovascular events, carotid artery disease, stroke, myocardial infarction
- Medical subject headings
- Carotid Artery Diseases, Stroke, Myocardial Infarction, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (1)
Relation of other demographic factors with carotid ultrasound and microwave radiometry measurements and outcome
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseaseStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Toutouzas, National and Kapodistrian University of Athens
- Investigators
- Konstantinos Toutouzas, Principal investigator, First department of Cardiology, University of Athens Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521351
- Sponsor's protocol ID
- MRcar
- Status last verified
- Sep 2019
- First submitted
- 25 Jan 2012
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21256490Toutouzas 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.
PubMed 25370590Toutouzas 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.
PubMed 24981292Toutouzas 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.
PubMed 23887842Toutouzas 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.
PubMed 30571323
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Natural History Study of Carotid Atherosclerosis
- ClinicalTrials.gov ID
- NCT01521351
- Acronym / sponsor ID
- MRcar
- Conditions
- Carotid Artery Disease, Stroke, Myocardial Infarction, Angina Pectoris
- Keywords
- microwave radiometry, cardiovascular events, carotid artery disease, stroke, myocardial infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease
Key inclusion criteria (1 listed)
- Consecutive patients with coronary artery disease admitted in our hospital
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Relation of other demographic factors with carotid ultrasound and microwave radiometry measurements and outcome
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Background: PubMed 21256490Toutouzas 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.
- Background: PubMed 25370590Toutouzas 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.
- Background: PubMed 24981292Toutouzas 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.
- Background: PubMed 23887842Toutouzas 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.
- Derived from this study: PubMed 30571323Toutouzas 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.
- related infoLink provided by the sponsor.
- Ippocration HospitalLink provided by the sponsor.
- University of Athens Medical SchoolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos Toutouzas contact
Andreas Synetos contact
Konstantinos Toutouzas principal investigator
First department of Cardiology, University of Athens Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Disease and Stroke, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konstantinos Toutouzas (ktoutouz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01521351, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.