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

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT05140434
• Lead Sponsor: Centre Hospitalier Sud Francilien

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.

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 Timeline

• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-12-01
• Study Start: 2022-05-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area Under the ROC curve	at 3 months	AUC of the ROC curve defined by DP increase and significant coronary artery stenosis or not

Secondary Outcome Measures

Name	Time	Method
ROC for women	at 3 months	AUC for women
Youden threshold	at 3 months	Maximalization of the difference between sensitivity and 1-specificity

Trial Locations

Locations (1)

CHARANSONNEY Olivier; 🇫🇷 Corbeil-essonnes Cedex, France