Epicardial FatRisqOScanNCT03111693
CT Evaluation of Cardiovascular Risk Markers in Obese Patients
An observational study of Epicardial Fat and Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Obesity is a chronic metabolic disorder : it leads to coronary heart disease and early atherosclerosis. Coronary artery calcium measured by CT is known as a robust predictor to predict risk for cardiac events in symptomatic and asymptomatic individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epicardial Fat, Obesity, Cardiovascular Risks Markers
- What is being tested?
- Unenhanced Coro-CT
- How many people
- 123 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: obese population
Who may be able to join
- obesity >30 indicated non enhanced coroCT for calcium scoring.
Who cannot join
- <18 ans
- low Framingham scoring
- pregnancy
- not providing informed consent
- history of cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Lucie CASSAGNES
About this study
Obesity is a chronic metabolic disorder : it leads to coronary heart disease and early atherosclerosis.
Coronary artery calcium measured by CT is known as a robust predictor to predict risk for cardiac events in symptomatic and asymptomatic individuals. Furthermore, recent studies show that other CT risk factor exists, independent of calcium scoring, such as epicardial fat, intrathoracic fat and visceral fat.
The aim of this prospective study is to evaluate these new cardiovascular risk markers in obese patients, using standard dose CT and low dose CT with adaptative statistical iterative reconstruction.
Read the detailed description
In this prospective single-center study, obese patients of our clinical nutrition service, hospitalized for nutritional assessement, are included.
All unenhanced coroCT examinations are performed on the same 64-Row CT scanner (discovery CT 750 HD scanner, GE Healthcare), using prospective ECG-triggerring. The investigation protocol began with a standard-dose acquisition followed immediately by a low-dose acquisition, recorded over strictly identical segments (identical first and last sections).
After these two examinations, estimated dose values are less than the diagnostic scan reference level for a coroCT.
- Conditions
- Epicardial Fat, Obesity, Cardiovascular Risks Markers, Metabolic Syndrome, Low Dose Computed Tomography
- Being tested
- Unenhanced Coro-CT
- Keywords
- Epicardial fat, Obesity, Cardiovascular risks markers, Metabolic syndrome, Low dose computed tomography
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unenhanced Coro-CTOther
All unenhanced coroCT examinations are performed on the same 64-Row CT scanner (discovery CT 750 HD scanner, GE Helthcare), using prospective ECG-triggerring.
| Study group | Role | What they receive |
|---|---|---|
| obese patients | obese patients of our clinical nutrition service, hospitalized for nutrional assessement, are included. Receives: Other: Unenhanced Coro-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epicardial fat evaluation in obese population
Measured: at day 1
Secondary outcomes (1)
Calcium scoring evaluation
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study startNov 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epicardial FatStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucie CASSAGNES, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111693
- Sponsor's protocol ID
- CHU-312
- Other IDs
- 2014-A00975-42
- Acronym
- RisqOScan
- Status last verified
- Apr 2017
- First submitted
- 30 Mar 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Evaluation of Cardiovascular Risk Markers in Obese Patients
- ClinicalTrials.gov ID
- NCT03111693
- Acronym / sponsor ID
- RisqOScan / CHU-312
- Conditions
- Epicardial Fat, Obesity, Cardiovascular Risks Markers, Metabolic Syndrome, Low Dose Computed Tomography
- Keywords
- Epicardial fat, Obesity, Cardiovascular risks markers, Metabolic syndrome, Low dose computed tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Apr 2017 (actual)
- 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.
Obesity is a chronic metabolic disorder : it leads to coronary heart disease and early atherosclerosis.
Coronary artery calcium measured by CT is known as a robust predictor to predict risk for cardiac events in symptomatic and asymptomatic individuals. Furthermore, recent studies show that other CT risk factor exists, independent of calcium scoring, such as epicardial fat, intrathoracic fat and visceral fat.
The aim of this prospective study is to evaluate these new cardiovascular risk markers in obese patients, using standard dose CT and low dose CT with adaptative statistical iterative reconstruction.
Detailed description
In this prospective single-center study, obese patients of our clinical nutrition service, hospitalized for nutritional assessement, are included.
All unenhanced coroCT examinations are performed on the same 64-Row CT scanner (discovery CT 750 HD scanner, GE Healthcare), using prospective ECG-triggerring. The investigation protocol began with a standard-dose acquisition followed immediately by a low-dose acquisition, recorded over strictly identical segments (identical first and last sections).
After these two examinations, estimated dose values are less than the diagnostic scan reference level for a coroCT.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obese patients | – | Other: Unenhanced Coro-CTobese patients of our clinical nutrition service, hospitalized for nutrional assessement, are included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- obese population
Key inclusion criteria (1 listed)
- obesity >30 indicated non enhanced coroCT for calcium scoring.
Key exclusion criteria (5 listed)
- <18 ans
- low Framingham scoring
- pregnancy
- not providing informed consent
- history of cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unenhanced Coro-CTAll unenhanced coroCT examinations are performed on the same 64-Row CT scanner (discovery CT 750 HD scanner, GE Helthcare), using prospective ECG-triggerring. | Other | obese patients |
Primary outcome
Epicardial fat evaluation in obese population
Time frame: at day 1
1 secondary outcome
Calcium scoring evaluation
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
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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.
Lucie CASSAGNES principal investigator
University Hospital, Clermont-Ferrand
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 Epicardial Fat and Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 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 13 Apr 2017. 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 France. 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 Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epicardial fat evaluation in obese population (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2017.