NCT03059550

Brief Summary

Because prevalence of glucose metabolism disorders is high in patients with coronary disease, the Oral Glucose Tolerance Test (OGTT) is recommended in all patients without diabetes after an acute coronary syndrome (ACS). However, there are some concerns about its performance in clinical practice. The aim of our study was to evaluate, after an acute coronary syndrome (ACS), the feasibility and efficacy of the OGTT in a cardiac rehabilitation (CR) center in comparison with its real application in the whole French population.

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
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

2.2 years

First QC Date

February 16, 2017

Last Update Submit

July 18, 2018

Conditions

Diabetes

Keywords

cardiac rehabilitationprediabetes

Outcome Measures

Primary Outcomes (1)

  • Percentage of OGTT performed after an acute coronary syndrome

    Percentage of OGTT performed after an acute coronary syndrome

    26 months

Secondary Outcomes (2)

  • Abnormalities of glucose metabolism diagnosed in cardiac rehabilitation

    26 months

  • Profile of the patients according to their glucose abnormalities

    26 months

Study Arms (2)

cardiac rehabilitation

Patients reffered to cardiac Rehabilitation after an acute coronary syndrome

Whole French population post-ACS

The whole French population who presented an acute coronary syndrome (ACS) in the years 2013 and 2014.

Eligibility Criteria

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

patients referred to cardiac rehabilitation after an acute coronary syndrome

You may qualify if:

  • patients referred to cardiac rehabilitation after an acute coronary syndrome during the 6 precious weeks

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon

Dijon, Burgundy, 21000, France

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusPrediabetic State

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Bruno Vergès, MD, PhD

    CHU Dijon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Vergès, MD, PhD

CONTACT

+33 380 293453bruno.verges@chu-dijon.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 23, 2017

Study Start

March 1, 2013

Primary Completion

May 31, 2015

Study Completion

December 31, 2020

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations

FR(1)