CT Evaluation of Cardiovascular Risk Markers in Obese Patients

Obesity Clinical Trial

— RisqOScan  

Official title:

CT Evaluation of Cardiovascular Risk Markers in Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03111693
• Other study ID #: CHU-312
• Secondary ID: 2014-A00975-42
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2017
• Last updated: April 7, 2017
• Start date: November 2014
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 123
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epicardial fat evaluation in obese population		at day 1
Secondary	Calcium scoring evaluation		at day 1