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

Coronary Artery Disease Clinical Trial

— DP-Cor-1  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05140434
• Other study ID #: 2021/0054
• Status: Recruiting
• Start date: May 4, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Sud Francilien
• Contact: Olivier CHARANSONNEY, MD
• Phone: 0161697766
• Email: olivier.charansonney[@]chsf.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Stenosis

Intervention

Diagnostic Test:
• Exercise test
exercise test on an exercise bike with increasing load
• Cardiac CT
cardiac CT scan

Locations

Country	Name	City	State
France	CHARANSONNEY Olivier	Corbeil-essonnes Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Youden threshold	Maximalization of the difference between sensitivity and 1-specificity	at 3 months
Secondary	ROC for women	AUC for women	at 3 months