Clinical trial NCT05140434: Evaluation of the Benefit of Exercise Testing for the Diagnosis of Obstruction in the Coronary Arteries of the Heart
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Exercise testing
coronary stenosis
double product
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Out-patients attending Centre Hospitalier Sud Francilien's cardiology department.

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

Eligibility criteria: 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

Primary outcomes:
measure: Area Under the ROC curve
timeFrame: at 3 months
Secondary outcomes:
measure: Youden threshold
timeFrame: at 3 months
measure: ROC for women
timeFrame: at 3 months
Other outcomes:
Locations:
city: Corbeil-essonnes Cedex
country: France
facility: CHARANSONNEY Olivier
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Olivier CHARANSONNEY, MD
role: PRINCIPAL_INVESTIGATOR
References: