Coronary Artery DiseaseNCT03543241
MyoStrain CMR Testing of Ischemia With Low Levels of Stress
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Myocardial Solutions at 1 site in United States.
Trial summary
This prospective, observational study evaluates the accuracy of stress testing with the MyoStrain SENC CMR Imaging System to detect myocardial ischemia and viability in patients with suspected coronary artery disease using low levels of stress. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia, Myocardial Dysfunction
- What is being tested?
- MyoStrain
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2017to 18 Oct 2018
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known or suspected coronary artery disease scheduled for cardiac catheterization.
Who may be able to join
- Known or suspected Coronary Artery Disease
- Symptoms potentially due to CAD; stable angina
- Positive imaging stress test or negative stress test but typical angina or anginal equivalent
- Negative Troponin with unstable angina
- Invasive coronary angiography planned within 3 months of CMR
- Provided written consent
Who cannot join
- Pregnancy
- Contraindication to Magnetic Resonance Imaging
- Prior allergy to Dobutamine
- Severe aortic stenosis
- Hypertrophic Cardiomyopathy
- Clinically significant Ventricular Tachycardia that would prohibit Dobutamine administration
Trial locations and contacts
1 site in 1 country.
About this study
This prospective, observational study evaluates the accuracy of stress testing with the MyoStrain SENC CMR Imaging System to detect myocardial ischemia and viability in patients with suspected coronary artery disease using low levels of stress.
Read the detailed description
This prospective, single center study evaluates the MyoStrain SENC CMR Imaging System for the detection of myocardial ischemia and viability during conventional Cardiac Magnetic Resonance (CMR) wall motion stress testing. Patients with known or suspected coronary artery disease and scheduled for cardiac catheterization will be consented for inclusion in the study and evaluated during stress testing with low dose Dobutamine as the stressor agent. Data obtained with the MyoStrain SENC CMR Imaging System will be for observational purposes and will not be used to alter patient management.
- Being tested
- MyoStrain
- Keywords
- Strain
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoStrainDiagnostic test
Prior to cardiac catheterization, patients will be stress testing with low dose Dobutamine to evaluate wall motion, segmental, and global myocardial strain at rest and under stress to determine the accuracy of detecting ischemia and viability of myocardial tissue.
| Study group | Role | What they receive |
|---|---|---|
| MyoStrain | Patients with suspected CAD and scheduled for cardiac catheterization will receive traditional CMR wall motion stress testing with MyoStrain software analysis of myocardial ischemia and viability. Receives: Diagnostic Test: MyoStrain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Ischemic CAD Detection
Sensitivity of correctly identifying ischemic coronary artery disease based on cardiac catheterization results using low dose Dobutamine stress testing with MyoStrain software
Measured: Up to coronary angiography within 1 month of standard CMR stress testing
Secondary outcomes (1)
Specificity of Ischemic CAD Detection
Specificity of correctly screening patients with ischemic coronary artery disease based on cardiac catheterization results using MyoStrain stress testing with low dose Dobutamine
Measured: Up to coronary angiography within 1 month of standard CMR stress testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start8 Nov 2017
- Primary completion12 Sep 2018
- Study completion18 Oct 2018
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myocardial Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frances Wood, MD, Principal investigator, WakeMed Health and Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543241
- Sponsor's protocol ID
- VAL-1006P(A)
- Status last verified
- Dec 2018
- First submitted
- 17 May 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyoStrain CMR Testing of Ischemia With Low Levels of Stress
- ClinicalTrials.gov ID
- NCT03543241
- Acronym / sponsor ID
- VAL-1006P(A)
- Keywords
- Strain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Myocardial SolutionsIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 1 Jun 2018 (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.
This prospective, observational study evaluates the accuracy of stress testing with the MyoStrain SENC CMR Imaging System to detect myocardial ischemia and viability in patients with suspected coronary artery disease using low levels of stress.
Detailed description
This prospective, single center study evaluates the MyoStrain SENC CMR Imaging System for the detection of myocardial ischemia and viability during conventional Cardiac Magnetic Resonance (CMR) wall motion stress testing. Patients with known or suspected coronary artery disease and scheduled for cardiac catheterization will be consented for inclusion in the study and evaluated during stress testing with low dose Dobutamine as the stressor agent. Data obtained with the MyoStrain SENC CMR Imaging System will be for observational purposes and will not be used to alter patient management.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyoStrain | – | Diagnostic Test: MyoStrainPatients with suspected CAD and scheduled for cardiac catheterization will receive traditional CMR wall motion stress testing with MyoStrain software analysis of myocardial ischemia and viability. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known or suspected coronary artery disease scheduled for cardiac catheterization.
Key inclusion criteria (6 listed)
- Known or suspected Coronary Artery Disease
- Symptoms potentially due to CAD; stable angina
- Positive imaging stress test or negative stress test but typical angina or anginal equivalent
- Negative Troponin with unstable angina
- Invasive coronary angiography planned within 3 months of CMR
Key exclusion criteria (6 listed)
- Pregnancy
- Contraindication to Magnetic Resonance Imaging
- Prior allergy to Dobutamine
- Severe aortic stenosis
- Hypertrophic Cardiomyopathy
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 |
|---|---|---|
| MyoStrainPrior to cardiac catheterization, patients will be stress testing with low dose Dobutamine to evaluate wall motion, segmental, and global myocardial strain at rest and under stress to determine the accuracy of detecting ischemia and viability of myocardial tissue. | Diagnostic test | MyoStrain |
Primary outcome
Sensitivity of Ischemic CAD Detection
Time frame: Up to coronary angiography within 1 month of standard CMR stress testing
Sensitivity of correctly identifying ischemic coronary artery disease based on cardiac catheterization results using low dose Dobutamine stress testing with MyoStrain software
1 secondary outcome
Specificity of Ischemic CAD Detection
Time frame: Up to coronary angiography within 1 month of standard CMR stress testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Frances Wood, MD principal investigator
WakeMed Health and Hospitals
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 and Myocardial Ischemia, run by Myocardial Solutions at 1 site in United States.
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: finished, as of the sponsor's last update on 19 Dec 2018. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Ischemic CAD Detection (time frame: Up to coronary angiography within 1 month of standard CMR stress testing). 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 19 Dec 2018.