Evaluation of the Benefit of Exercise Testing for the Diagnosis of Obstruction in the Coronary Arteries of the Heart
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise test, Cardiac CT.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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 test Exercise test
exercise test on an exercise bike with increasing load - Diagnostic test Cardiac CT
cardiac CT scan
Primary outcome measures
- Area Under the ROC curve [Time frame: at 3 months]
Secondary outcome measures (2)
- Youden threshold [Time frame: at 3 months]
- ROC for women [Time frame: at 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHARANSONNEY Olivier — Corbeil-Essonnes
Identifiers
NCT: NCT05140434 · 2021/0054