CT Evaluation of Cardiovascular Risk Markers in Obese Patients

NCT ID: NCT03111693

Last Updated: 2017-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Epicardial Fat Obesity Cardiovascular Risks Markers Metabolic Syndrome Low Dose Computed Tomography

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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obese patients

obese patients of our clinical nutrition service, hospitalized for nutrional assessement, are included.

Unenhanced Coro-CT

Intervention Type OTHER

All unenhanced coroCT examinations are performed on the same 64-Row CT scanner (discovery CT 750 HD scanner, GE Helthcare), using prospective ECG-triggerring.

Interventions

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Unenhanced Coro-CT

All unenhanced coroCT examinations are performed on the same 64-Row CT scanner (discovery CT 750 HD scanner, GE Helthcare), using prospective ECG-triggerring.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* obesity \>30 indicated non enhanced coroCT for calcium scoring.

Exclusion Criteria

* \<18 ans
* low Framingham scoring
* pregnancy
* not providing informed consent
* history of cardiovascular disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucie CASSAGNES

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Facility Contacts

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Patrick LACARIN

Role: primary

04 73 75 11 95

Other Identifiers

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2014-A00975-42

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-312

Identifier Type: -

Identifier Source: org_study_id

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