Evaluation of the Benefit of Exercise Testing for the Diagnosis of Obstruction in the Coronary Arteries of the Heart

NCT05140434 | Recruiting

• 1 other identifier: 2021/0054
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether exercise testing can detect an obstruction in a coronary artery, and, thereby, can avoid performing a coronary imaging in some cases. Patients with a suspicion of coronary artery disease perform an exercise test on an exercise bike with increasing load. EKG, blood pressure, and other parameters are monitored. Patients benefit also of either a cardiac CT scan or a coronary angiography to establish whether they really have coronary obstruction.

Conditions

Coronary Artery Disease

Keywords

Exercise testing; coronary stenosis; double product

Outcome Measures

Primary Outcomes (1)

• Area Under the ROC curve

  AUC of the ROC curve defined by DP increase and significant coronary artery stenosis or not

  at 3 months

Secondary Outcomes (2)

• Youden threshold

  at 3 months

• ROC for women

  at 3 months

Interventions

Exercise test DIAGNOSTIC_TEST

exercise test on an exercise bike with increasing load

Cardiac CT DIAGNOSTIC_TEST

cardiac CT scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Out-patients attending Centre Hospitalier Sud Francilien's cardiology department.

You may qualify if:

• Starting betweew 1/1/2019 and 3/1/2022
• year-old patients or older
• Patients with both exercise testing and either Cardiac CT or coronary angiography within 3 months
• Patients informed and not opposing to their participation to the study

You may not qualify if:

• Patients unable to fully understand the information related to the study

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

CHARANSONNEY Olivier

Corbeil-Essonnes, France, 91106, France

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Olivier CHARANSONNEY, MD

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier CHARANSONNEY, MD

CONTACT

0161697766; olivier.charansonney@chsf.fr

Caroline TOURTE

CONTACT

0161693730; caroline.tourte@chsf.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 1, 2021
• Study Start: May 4, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)