CT Evaluation of Cardiovascular Risk Markers in Obese Patients

• Conditions: Obesity; Cardiovascular Risks Markers; Metabolic Syndrome; Low Dose Computed Tomography; Epicardial Fat
• Interventions: Other: Unenhanced Coro-CT

• Registration Number: NCT03111693
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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. 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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2017-03-30
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-07
• Last Update Submitted: 2017-04-07
• Study First Posted: 2017-04-13
• Last Update Posted: 2017-04-13
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 123

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
obese patients	Unenhanced Coro-CT	obese patients of our clinical nutrition service, hospitalized for nutrional assessement, are included.

Primary Outcome Measures

Name	Time	Method
Epicardial fat evaluation in obese population	at day 1

Secondary Outcome Measures

Name	Time	Method
Calcium scoring evaluation	at day 1

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France