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NCT Number: NCT05140434

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHARANSONNEY Olivier

Corbeil-Essonnes, France, 91106

Location status: Recruiting

Location contact

Olivier CHARANSONNEY, MD

CONTACT

[email protected]

01 61 69 77 66

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise test

Diagnostic Test

exercise test on an exercise bike with increasing load

cardiac CT

Diagnostic Test

cardiac CT scan

Primary outcomes

  1. Area Under the ROC curve

    Time frame: at 3 months

    AUC of the ROC curve defined by DP increase and significant coronary artery stenosis or not

Secondary outcomes

  1. Youden threshold

    Time frame: at 3 months

    Maximalization of the difference between sensitivity and 1-specificity

  2. ROC for women

    Time frame: at 3 months

    AUC for women

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline TOURTE

CONTACT

[email protected]

0161693730

Olivier CHARANSONNEY, MD

CONTACT

[email protected]

0161697766

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Official study 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.

Acronym: DP-Cor-1

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 1, 2021
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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