Myocardial Perfusion, Coronary Flow Reserve and Kinetic Analysis During Dobutamine Stress Echocardiography (TRIPLESTRESS)

September 11, 2023 updated by: Fondation Hôpital Saint-Joseph

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
201

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: GARCON Philippe, MD
  • Phone Number: +33 0144127693
  • Email: pgarcon@hpsj.fr

Study Contact Backup

  • Name: Helene BEAUSSIER, PharmD, PhD
  • Phone Number: +33 0144127883
  • Email: crc@hpsj.fr

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stress echocardiography

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.
Diagnostic test: Stress echocardiography

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1
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.
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of complications
Time Frame: Year 2
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.
Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondation Hôpital Saint-Joseph

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philippe P GARCON, MD, Fondation Hôpital Saint-Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRIPLESTRESS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Disease

Clinical Trials on Stress echocardiography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings