Coronary DiseaseTRIPLESTRESSNCT03996499
Myocardial Perfusion, Coronary Flow Reserve and Kinetic Analysis During Dobutamine Stress Echocardiography
A study testing Stress echocardiography in people with Coronary Disease, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Stress echocardiography is a screening test for coronary heart disease that already has good sensitivity and specificity (both around 70%). This examination is mainly offered to stable patients, consulting externally, in order to detect ischemic heart disease in the same way as would a myocardial scintigraphy or MRI… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Stress echocardiography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patient whose age ≥ 18 years
- Patient referred for stress echography in the context of a cardiovascular assessment or for suspicion of coronary disease
- Patient whose echogenicity requires the use of an ultrasound contrast product (SONOVUE®) according to European Society of Cardiology recommendations
- Patient affiliated with a health insurance plan
- Francophone patient
- Patient able to give free, informed and written oral consent
Who cannot join
- People in emergency situations (recent acute coronary syndromes) who can not express their prior consent
- Patient with an allergy to any of the products used
- Patient for whom it is impossible to obtain a theoretical maximum frequency (continued beta-blocker treatment, chronotropic insufficiency)
- Pregnant woman
- Patient under tutorship or curatorship
- Patient deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Stress echocardiography is a screening test for coronary heart disease that already has good sensitivity and specificity (both around 70%). This examination is mainly offered to stable patients, consulting externally, in order to detect ischemic heart disease in the same way as would a myocardial scintigraphy or MRI stress. This examination is an echocardiographic modality consisting in visualizing and analyzing the modifications of the contraction of the cardiac muscle during a stress constituted by an effort or by injection of certain drugs. Stress echocardiography is performed by injection of drugs to reproduce the conditions of the effort. The products used to perform this examination are initially an intravenous infusion of dobutamine, atropine whose effect is to increase the heart rate, and in a second time, an intravenous infusion of beta-blockers or a bradycardic calcium channel blocker at the end of the procedure whose effect is to slow down the heart rate.
The use of echographic contrast medium, allowing a better visibility, is recommended for the realization of a stress ultrasound, since the echogenicity is judged insufficient on two segments (segmentation of the left ventricle in 17 segments).
Read more
The analysis of dobutamine stress echocardiography currently relies solely on the analysis of segmental kinetics, namely the quality of the thickening of the endocardium. When segmental kinetics are abnormal, patients benefit from a coronary CT scan or coronary angiography to visualize all the coronary arteries and to check whether there is a narrowing of the arteries.
Moreover, stress echocardiography performed using a contrast medium makes it possible to analyze two other indices in addition to segmental kinetics.
Thus, the second parameter that can be analyzed corresponds to the Coronary Flow Reserve measurement, thanks to the easy identification of the Doppler flow in the anterior interventricular at rest and peak of dobutamine. The coronal reserve is well validated with adenosine, but much less well known under dobutamine.
The third parameter that can be analyzed is myocardial perfusion. By using appropriate settings, it is possible to see the microbubbles in the thickness of the myocardium. These bubbles are then destroyed by an ultrasonic flash of high mechanical index. This results in the destruction of all intra-myocardial bubbles. The analysis of the myocardial perfusion is based on the rate of reappearance of these bubbles (through the coronary arteries) at rest and peak stress. In case of significant stenosis or coronary occlusion, there is a delay or complete absence of perfusion in the territory concerned.
Joint analysis of segmental kinetics, coronary reserve and myocardial perfusion has already been described with adenosine, but not with dobutamine. Studies in the literature suggest that the analysis of coronary reserve on the one hand, and myocardial perfusion on the other hand would increase the sensitivity and specificity of the examination. In addition, other studies suggest that among the tests considered normal for segmental kinetics analysis, there are patients with myocardial perfusion abnormality and / or coronary reserve abnormality that strike (s) on prognosis (alteration of the coronary microcirculation).
This is why it seems interesting to compare the results of these 3 indices obtained during stress echocardiography under dobutamine.
- Conditions
- Coronary Disease
- Being tested
- Stress echocardiography
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress echocardiographyDiagnostic test
The course of the examination corresponds to the welcome of the patient, the search for contraindications and the performance of the stress ultrasound. During this stress ultrasound, the 3 indices (segmental kinetics, coronary reserve and myocardial perfusion) will be analyzed. The duration of the ultrasound is not lengthened (examination time: 20 minutes).
The evaluation of the myocardial perfusion is carried out thanks to the use of the "flash", modality not being part of the usual care.
Indeed, during the examination, the power of the probe will be increased to evaluate the myocardial perfusion. The bubbles of the contrast medium are destroyed by applying a "flash", that is to say a transient increase in the power of the ultrasonic beam. Systole after systole, on a recorded loop, the filling rate of the myocardium, which depends on the myocardial blood flow, is analyzed. The evaluation of the infusion is visual and qualitative.
| Study group | Role | What they receive |
|---|---|---|
| Stress echocardiography | Experimental | The course of the examination corresponds to the welcome of the patient, the search for contraindications and the performance of the stress ultrasound. During this stress ultrasound, the 3 indices (segmental kinetics, coronary reserve and myocardial perfusion) will be analyzed. The duration of the ultrasound is not lengthened (examination time: 20 minutes).
The evaluation of the myocardial perfusion is carried out thanks to the use of the "flash", modality not being part of the usual care.
Indeed, during the examination, the power of the probe will be increased to evaluate the myocardial perfusion. The bubbles of the contrast medium are destroyed by applying a "flash", that is to say a transient increase in the power of the ultrasonic beam. Systole after systole, on a recorded loop, the filling rate of the myocardium, which depends on the myocardial blood flow, is analyzed. The evaluation of the infusion is visual and qualitative. Receives: Diagnostic Test: Stress echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the combined analysis
This is to measure the sensitivity of segmental kinetics, coronary reserve and myocardial perfusion compared to simple segmental kinetic analysis alone to detect coronary artery disease.
Measured: Day 1
Specificity of the combined analysis
This is to measure the specificity of segmental kinetics, coronary reserve and myocardial perfusion compared to simple segmental kinetic analysis alone to detect coronary artery disease.
Measured: Day 1
Secondary outcomes (1)
Rate of complications
This is to measure rate of cardiovascular mortality, hospitalization for acute coronary syndromes or emergency coronary revascularization in patients with negative examination on 1, 2 or 3 index.
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start20 Jun 2019
- Primary completion10 Sep 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The course of the examination corresponds to the welcome of the patient, the search for contraindications and the performance of the stress ultrasound. During this stress ultrasound, the 3 indices (segmental kinetics, coronary reserve and myocardial perfusion) will be analyzed. The duration of the ultrasound is not lengthened (examination time: 20 minutes). The evaluation of the myocardial perfusion is carried out thanks to the use of the "flash", modality not being part of the usual care. Indeed, during the examination, the power of the probe will be increased to evaluate the myocardial perfusion. The bubbles of the contrast medium are destroyed by applying a "flash", that is to say a transient increase in the power of the ultrasonic beam. Systole after systole, on a recorded loop, the filling rate of the myocardium, which depends on the myocardial blood flow, is analyzed. The evaluation of the infusion is visual and qualitative.
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe P GARCON, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996499
- Sponsor's protocol ID
- TRIPLESTRESS
- Acronym
- TRIPLESTRESS
- Status last verified
- Sep 2023
- First submitted
- 21 Jun 2019
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Perfusion, Coronary Flow Reserve and Kinetic Analysis During Dobutamine Stress Echocardiography
- ClinicalTrials.gov ID
- NCT03996499
- Acronym / sponsor ID
- TRIPLESTRESS / TRIPLESTRESS
- Conditions
- Coronary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 10 Sep 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Jun 2019 (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.
Stress echocardiography is a screening test for coronary heart disease that already has good sensitivity and specificity (both around 70%). This examination is mainly offered to stable patients, consulting externally, in order to detect ischemic heart disease in the same way as would a myocardial scintigraphy or MRI stress. This examination is an echocardiographic modality consisting in visualizing and analyzing the modifications of the contraction of the cardiac muscle during a stress constituted by an effort or by injection of certain drugs. Stress echocardiography is performed by injection of drugs to reproduce the conditions of the effort. The products used to perform this examination are initially an intravenous infusion of dobutamine, atropine whose effect is to increase the heart rate, and in a second time, an intravenous infusion of beta-blockers or a bradycardic calcium channel blocker at the end of the procedure whose effect is to slow down the heart rate.
The use of echographic contrast medium, allowing a better visibility, is recommended for the realization of a stress ultrasound, since the echogenicity is judged insufficient on two segments (segmentation of the left ventricle in 17 segments).
The analysis of dobutamine stress echocardiography currently relies solely on the analysis of segmental kinetics, namely the quality of the thickening of the endocardium. When segmental kinetics are abnormal, patients benefit from a coronary CT scan or coronary angiography to visualize all the coronary arteries and to check whether there is a narrowing of the arteries.
Moreover, stress echocardiography performed using a contrast medium makes it possible to analyze two other indices in addition to segmental kinetics.
Thus, the second parameter that can be analyzed corresponds to the Coronary Flow Reserve measurement, thanks to the easy identification of the Doppler flow in the anterior interventricular at rest and peak of dobutamine. The coronal reserve is well validated with adenosine, but much less well known under dobutamine.
The third parameter that can be analyzed is myocardial perfusion. By using appropriate settings, it is possible to see the microbubbles in the thickness of the myocardium. These bubbles are then destroyed by an ultrasonic flash of high mechanical index. This results in the destruction of all intra-myocardial bubbles. The analysis of the myocardial perfusion is based on the rate of reappearance of these bubbles (through the coronary arteries) at rest and peak stress. In case of significant stenosis or coronary occlusion, there is a delay or complete absence of perfusion in the territory concerned.
Joint analysis of segmental kinetics, coronary reserve and myocardial perfusion has already been described with adenosine, but not with dobutamine. Studies in the literature suggest that the analysis of coronary reserve on the one hand, and myocardial perfusion on the other hand would increase the sensitivity and specificity of the examination. In addition, other studies suggest that among the tests considered normal for segmental kinetics analysis, there are patients with myocardial perfusion abnormality and / or coronary reserve abnormality that strike (s) on prognosis (alteration of the coronary microcirculation).
This is why it seems interesting to compare the results of these 3 indices obtained during stress echocardiography under dobutamine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The course of the examination corresponds to the welcome of the patient, the search for contraindications and the performance of the stress ultrasound. During this stress ultrasound, the 3 indices (segmental kinetics, coronary reserve and myocardial perfusion) will be analyzed. The duration of the ultrasound is not lengthened (examination time: 20 minutes). The evaluation of the myocardial perfusion is carried out thanks to the use of the "flash", modality not being part of the usual care. Indeed, during the examination, the power of the probe will be increased to evaluate the myocardial perfusion. The bubbles of the contrast medium are destroyed by applying a "flash", that is to say a transient increase in the power of the ultrasonic beam. Systole after systole, on a recorded loop, the filling rate of the myocardium, which depends on the myocardial blood flow, is analyzed. The evaluation of the infusion is visual and qualitative.
| Arm | Type | Receives |
|---|---|---|
| Stress echocardiography | Experimental | Diagnostic Test: Stress echocardiographyThe course of the examination corresponds to the welcome of the patient, the search for contraindications and the performance of the stress ultrasound. During this stress ultrasound, the 3 indices (segmental kinetics, coronary reserve and myocardial perfusion) will be analyzed. The duration of the ultrasound is not lengthened (examination time: 20 minutes). The evaluation of the myocardial perfusion is carried out thanks to the use of the "flash", modality not being part of the usual care. Indeed, during the examination, the power of the probe will be increased to evaluate the myocardial perfusion. The bubbles of the contrast medium are destroyed by applying a "flash", that is to say a transient increase in the power of the ultrasonic beam. Systole after systole, on a recorded loop, the filling rate of the myocardium, which depends on the myocardial blood flow, is analyzed. The evaluation of the infusion is visual and qualitative. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient whose age ≥ 18 years
- Patient referred for stress echography in the context of a cardiovascular assessment or for suspicion of coronary disease
- Patient whose echogenicity requires the use of an ultrasound contrast product (SONOVUE®) according to European Society of Cardiology recommendations
- Patient affiliated with a health insurance plan
- Francophone patient
Key exclusion criteria (6 listed)
- People in emergency situations (recent acute coronary syndromes) who can not express their prior consent
- Patient with an allergy to any of the products used
- Patient for whom it is impossible to obtain a theoretical maximum frequency (continued beta-blocker treatment, chronotropic insufficiency)
- Pregnant woman
- Patient under tutorship or curatorship
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 |
|---|---|---|
| Stress echocardiographyThe course of the examination corresponds to the welcome of the patient, the search for contraindications and the performance of the stress ultrasound. During this stress ultrasound, the 3 indices (segmental kinetics, coronary reserve and myocardial perfusion) will be analyzed. The duration of the ultrasound is not lengthened (examination time: 20 minutes). The evaluation of the myocardial perfusion is carried out thanks to the use of the "flash", modality not being part of the usual care. Indeed, during the examination, the power of the probe will be increased to evaluate the myocardial perfusion. The bubbles of the contrast medium are destroyed by applying a "flash", that is to say a transient increase in the power of the ultrasonic beam. Systole after systole, on a recorded loop, the filling rate of the myocardium, which depends on the myocardial blood flow, is analyzed. The evaluation of the infusion is visual and qualitative. | Diagnostic test | Stress echocardiography |
Primary outcome
Sensitivity of the combined analysis
Time frame: Day 1
This is to measure the sensitivity of segmental kinetics, coronary reserve and myocardial perfusion compared to simple segmental kinetic analysis alone to detect coronary artery disease.
Specificity of the combined analysis
Time frame: Day 1
This is to measure the specificity of segmental kinetics, coronary reserve and myocardial perfusion compared to simple segmental kinetic analysis alone to detect coronary artery disease.
1 secondary outcome
Rate of complications
Time frame: Year 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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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. This study is not recruiting at the moment.
Philippe P GARCON, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress echocardiography in people with Coronary Disease, run by Fondation Hôpital Saint-Joseph 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the combined analysis (time frame: Day 1). The study lists 2 primary outcomes in all. 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 13 Sep 2023.