Coronary Artery DiseaseDP-Cor-1NCT05140434
Evaluation of the Benefit of Exercise Testing for the Diagnosis of Obstruction in the Coronary Arteries of the Heart
An observational study of Coronary Artery Disease, run by Centre Hospitalier Sud Francilien at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Exercise test and Cardiac CT
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Out-patients attending Centre Hospitalier Sud Francilien's cardiology department.
Who may be able to join
- 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
Who cannot join
- Patients unable to fully understand the information related to the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHARANSONNEY Olivier
Corbeil-Essonnes, France, 91106
Olivier CHARANSONNEY, MD, 01 61 69 77 66, olivier.charansonney@chsf.fr
About this study
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.
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.
Read the 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
- Conditions
- Coronary Artery Disease
- Being tested
- Exercise test, Cardiac CT
- Keywords
- Exercise testing, coronary stenosis, double product
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise testDiagnostic test
exercise test on an exercise bike with increasing load
Cardiac CTDiagnostic test
cardiac CT scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the ROC curve
AUC of the ROC curve defined by DP increase and significant coronary artery stenosis or not
Measured: at 3 months
Secondary outcomes (2)
Youden threshold
Maximalization of the difference between sensitivity and 1-specificity
Measured: at 3 months
ROC for women
AUC for women
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start4 May 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier CHARANSONNEY, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140434
- Sponsor's protocol ID
- 2021/0054
- Acronym
- DP-Cor-1
- Status last verified
- Mar 2025
- First submitted
- 19 Nov 2021
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05140434
- Acronym / sponsor ID
- DP-Cor-1 / 2021/0054
- Conditions
- Coronary Artery Disease
- Keywords
- Exercise testing, coronary stenosis, double product
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Out-patients attending Centre Hospitalier Sud Francilien's cardiology department.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients unable to fully understand the information related to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise testexercise test on an exercise bike with increasing load | Diagnostic test | – |
| Cardiac CTcardiac CT scan | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
Youden threshold
Time frame: at 3 months
ROC for women
Time frame: at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivier CHARANSONNEY, MD principal investigator
Centre Hospitalier Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Centre Hospitalier Sud Francilien at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier CHARANSONNEY, MD (0161697766, olivier.charansonney@chsf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the ROC curve (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.