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

NCT ID: NCT05140434

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-04

Study Completion Date

2025-12-31

Brief Summary

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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

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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

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Exercise test

exercise test on an exercise bike with increasing load

Intervention Type DIAGNOSTIC_TEST

Cardiac CT

cardiac CT scan

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Sud Francilien

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier CHARANSONNEY, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sud Francilien

Locations

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CHARANSONNEY Olivier

Corbeil-Essonnes, France, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Olivier CHARANSONNEY, MD

Role: CONTACT

0161697766

Caroline TOURTE

Role: CONTACT

0161693730

Facility Contacts

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Olivier CHARANSONNEY, MD

Role: primary

01 61 69 77 66

Other Identifiers

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2021/0054

Identifier Type: -

Identifier Source: org_study_id

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