Evaluation of the Benefit of Exercise Testing for the Diagnosis of Obstruction in the Coronary Arteries of the Heart (DP-Cor-1)

March 12, 2025 updated by: Centre Hospitalier Sud Francilien

Evaluation of the Predictive Power of Double-product Increase Measured During an Exercise Test for the Prediction of Coronary Stenosis As Diagnosed by Cardiac CT Scan or Coronary Angiography.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Double product DP (product of systolic blood pressure and heart rate) is directly related to the myocardial oxygen consumption (MVO2). Since O2 extraction by the myocyte in maximal at rest, only an increase in coronary blood flow can increase MVO2 during exercise. Therefore, if a coronary stenosis limits the maximal coronary flow, it will limit MVO2 and DP at exercise.

Patients with both an exercise test and a coronary artery imaging (cardiac CT or coronary angiography) within 3 months, are included. DP increase (DP max/DP at rest) is measured during a maximal, symptom-limited exercise on a cycloergometer. DP at rest is measured either before the exercise test, at the end of the recovery period or during a visit to the cardiologist in the 2 months of the test, whichever is the smallest.

The predictive power to detect a significant coronary artery stenosis is assessed by computing a Receiving Operating Characteristic (ROC) curve, its area under the curve, sensitivity, specificity, and decision thresholds.

Number expected: 100-120 Time period of data collection: 1/1/2019 to 3/1/2022

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Corbeil-essonnes Cedex, France, 91106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Starting betweew 1/1/2019 and 3/1/2022
  • 18 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the ROC curve
Time Frame: at 3 months
AUC of the ROC curve defined by DP increase and significant coronary artery stenosis or not
at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Youden threshold
Time Frame: at 3 months
Maximalization of the difference between sensitivity and 1-specificity
at 3 months
ROC for women
Time Frame: at 3 months
AUC for women
at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Sud Francilien

Investigators

  • Principal Investigator: Olivier CHARANSONNEY, MD, Centre hospitalier Sud Francilien

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

November 19, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/0054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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