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

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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05140434
Acronym
DP-Cor-1
Enrollment
120
Registered
2021-12-01
Start date
2022-05-04
Completion date
2025-12-31
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Exercise testing, coronary stenosis, double product

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

Interventions

DIAGNOSTIC_TESTExercise test

exercise test on an exercise bike with increasing load

DIAGNOSTIC_TESTCardiac CT

cardiac CT scan

Sponsors

Centre Hospitalier Sud Francilien
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Area Under the ROC curveat 3 monthsAUC of the ROC curve defined by DP increase and significant coronary artery stenosis or not

Secondary

MeasureTime frameDescription
Youden thresholdat 3 monthsMaximalization of the difference between sensitivity and 1-specificity
ROC for womenat 3 monthsAUC for women

Countries

France

Contacts

Primary ContactOlivier CHARANSONNEY, MD
olivier.charansonney@chsf.fr0161697766
Backup ContactCaroline TOURTE
caroline.tourte@chsf.fr0161693730

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026