NCT03111693

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

3.1 years

First QC Date

March 30, 2017

Last Update Submit

April 7, 2017

Conditions

Epicardial FatObesityCardiovascular Risks MarkersMetabolic SyndromeLow Dose Computed Tomography

Keywords

Epicardial fatObesityCardiovascular risks markersMetabolic syndromeLow dose computed tomography

Outcome Measures

Primary Outcomes (1)

  • Epicardial fat evaluation in obese population

    at day 1

Secondary Outcomes (1)

  • Calcium scoring evaluation

    at day 1

Study Arms (1)

obese patients

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

Other: Unenhanced Coro-CT

Interventions

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.

obese patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

obese population

You may qualify if:

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

You may not qualify if:

  • \<18 ans
  • low Framingham scoring
  • pregnancy
  • not providing informed consent
  • history of cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Lucie CASSAGNES

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 13, 2017

Study Start

November 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations

FR(1)