Myocardial Infarction With Non-Obstructive Coronary ArteryCOPE-CMRNCT06323811
Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA and MINOCA-mimics
A study testing CMR in people with Myocardial Infarction With Non-Obstructive Coronary Artery and Myocarditis Acute, run by University of Zurich at 1 site in Switzerland.
Trial summary
This clinical study examines patients presenting with acute myocardial infarction and no significant coronary artery disease on coronary angiography (MINOCA) and patients with MINOCA-mimics with advanced CMR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction With Non-Obstructive Coronary Artery, Myocarditis Acute, Takotsubo Cardiomyopathy
- What is being tested?
- CMR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jun 2023to 31 Dec 2025
- 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
- acute presentation with signs/symptoms of acute coronary syndrome or myocarditis
- elevated cardiac biomarkers
- no signficant coronary artery disease on coronary angiogram or coronary CT
Who cannot join
- pacemaker/other devices or claustrophobia
- severe asthma, chronic obstructive lung or kidney disease
- acute pulmonary embolism
- arrhythmia on ECG
- moderate to severe valvular disease
Trial locations and contacts
1 site in 1 country.
Verena C Wilzeck, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Robert Manka
About this study
Official title: Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA, Tako-Tsubo, SCAD, Myocarditis and NSTEMI in the Acute Phase and Post Convalescence
This clinical study examines patients presenting with acute myocardial infarction and no significant coronary artery disease on coronary angiography (MINOCA) and patients with MINOCA-mimics with advanced CMR.
The present study aims to:
Read more
- assess the microvascular function with a novel quantitative 3D myocardial perfusion imaging approach in the acute phase and post-convalescence
- refine the role and diagnostic potential of advanced quantitative CMR imaging
- assess the potential prognostic significance of microvascular dysfunction and epicardial adipose tissue on cardiovascular outcomes
Participants will undergo advanced CMR imaging in the acute setting (within 10 days after event) and post convalescence (after 3 months).
Read the detailed description
Advanced CMR includes a novel free-breathing motion-informed locally low-rank quantitative 3D myocardial perfusion imaging. Perfusion imaging will be compared with 3D late gadolinium enhancement (LGE) imaging. A cine Dixon sequence is performed for the assessment of epicardial adipose tissue (EAT).
- Conditions
- Myocardial Infarction With Non-Obstructive Coronary Artery, Myocarditis Acute, Takotsubo Cardiomyopathy, Spontaneous Coronary Artery Dissection, Non ST Elevation Myocardial Infarction
- Being tested
- CMR
- Keywords
- MINOCA, MINOCA-mimics, CMR, 3D perfusion, advanced CMR imaging
- Medical subject headings
- MINOCA, Takotsubo Cardiomyopathy, Coronary Artery Dissection, Spontaneous, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMRDiagnostic test
Advanced CMR imaging including a novel quantitative free-breathing 3D perfusion sequence, 3D LGE imaging and a cine Dixon sequence
| Study group | Role | What they receive |
|---|---|---|
| MINOCA | Experimental | Patients with myocardial infarction with non-obstructive coronary artery disease (MINOCA) prospectively investigated with advanced CMR Receives: Diagnostic Test: CMR |
| Myocarditis | Experimental | Patients with suspected myocarditis prospectively investigated with advanced CMR Receives: Diagnostic Test: CMR |
| Takotsubo cardiomyopathy | Experimental | Patients with suspected Takotsubo cardiomyopathy prospectively investigated with advanced CMR Receives: Diagnostic Test: CMR |
| Spontaneous coronary artery dissection (SCAD) | Experimental | Patients with suspected/diagnosed spontaneous coronary artery dissection prospectively investigated with advanced CMR Receives: Diagnostic Test: CMR |
| NSTEMI | Active comparator | Patients with confirmed non-ST elevation myocardial infarction on coronary angiography prospectively investigated with advanced CMR Receives: Diagnostic Test: CMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial perfusion reserve index
comparison of microvascular function in the acute phase versus post convalescence
Measured: within 10 days and after 3 months after index event
Secondary outcomes (2)
epicardial adipose tissue (EAT)
the amount of epicardial adipose tissue
Measured: 4 months (measured either at first or second CMR)
cardiovascular events
rate of cardiovascular death, myocardial infarction, recurrence of MINOCA, myocarditis, takotsubo cardiomyopathy, SCAD
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start15 Jun 2023
- Primary completion30 Jun 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 Myocardial Infarction With Non-Obstructive Coronary ArteryStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 5 groups of patients (MINOCA, myocarditis, Takotsubo cardiomyopathy, SCAD, NSTEMI) will undergo CMR with 3D perfusion in the acute setting (within 10 days after the event) and post convalescence (after 3 months)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich
- Responsible party
- Sponsor
- Investigators
- Robert Manka, Prof. MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323811
- Sponsor's protocol ID
- COPE CMR
- Acronym
- COPE-CMR
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 21 Mar 2024
- 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 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA, Tako-Tsubo, SCAD, Myocarditis and NSTEMI in the Acute Phase and Post Convalescence
- ClinicalTrials.gov ID
- NCT06323811
- Acronym / sponsor ID
- COPE-CMR / COPE CMR
- Conditions
- Myocardial Infarction With Non-Obstructive Coronary Artery, Myocarditis Acute, Takotsubo Cardiomyopathy, Spontaneous Coronary Artery Dissection, Non ST Elevation Myocardial Infarction
- Keywords
- MINOCA, MINOCA-mimics, CMR, 3D perfusion, advanced CMR imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- ETH Zurich
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Mar 2024 (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 clinical study examines patients presenting with acute myocardial infarction and no significant coronary artery disease on coronary angiography (MINOCA) and patients with MINOCA-mimics with advanced CMR.
The present study aims to:
- assess the microvascular function with a novel quantitative 3D myocardial perfusion imaging approach in the acute phase and post-convalescence
- refine the role and diagnostic potential of advanced quantitative CMR imaging
- assess the potential prognostic significance of microvascular dysfunction and epicardial adipose tissue on cardiovascular outcomes
Participants will undergo advanced CMR imaging in the acute setting (within 10 days after event) and post convalescence (after 3 months).
Detailed description
Advanced CMR includes a novel free-breathing motion-informed locally low-rank quantitative 3D myocardial perfusion imaging. Perfusion imaging will be compared with 3D late gadolinium enhancement (LGE) imaging. A cine Dixon sequence is performed for the assessment of epicardial adipose tissue (EAT).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
- Model description
- 5 groups of patients (MINOCA, myocarditis, Takotsubo cardiomyopathy, SCAD, NSTEMI) will undergo CMR with 3D perfusion in the acute setting (within 10 days after the event) and post convalescence (after 3 months)
| Arm | Type | Receives |
|---|---|---|
| MINOCA | Experimental | Diagnostic Test: CMRPatients with myocardial infarction with non-obstructive coronary artery disease (MINOCA) prospectively investigated with advanced CMR |
| Myocarditis | Experimental | Diagnostic Test: CMRPatients with suspected myocarditis prospectively investigated with advanced CMR |
| Takotsubo cardiomyopathy | Experimental | Diagnostic Test: CMRPatients with suspected Takotsubo cardiomyopathy prospectively investigated with advanced CMR |
| Spontaneous coronary artery dissection (SCAD) | Experimental | Diagnostic Test: CMRPatients with suspected/diagnosed spontaneous coronary artery dissection prospectively investigated with advanced CMR |
| NSTEMI | Active comparator | Diagnostic Test: CMRPatients with confirmed non-ST elevation myocardial infarction on coronary angiography prospectively investigated with advanced CMR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- acute presentation with signs/symptoms of acute coronary syndrome or myocarditis
- elevated cardiac biomarkers
- no signficant coronary artery disease on coronary angiogram or coronary CT
Key exclusion criteria (5 listed)
- pacemaker/other devices or claustrophobia
- severe asthma, chronic obstructive lung or kidney disease
- acute pulmonary embolism
- arrhythmia on ECG
- moderate to severe valvular disease
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 |
|---|---|---|
| CMRAdvanced CMR imaging including a novel quantitative free-breathing 3D perfusion sequence, 3D LGE imaging and a cine Dixon sequence | Diagnostic test | MINOCA, Myocarditis, NSTEMI, Spontaneous coronary artery dissection (SCAD), Takotsubo cardiomyopathy |
Primary outcome
Myocardial perfusion reserve index
Time frame: within 10 days and after 3 months after index event
comparison of microvascular function in the acute phase versus post convalescence
2 secondary outcomes
epicardial adipose tissue (EAT)
Time frame: 4 months (measured either at first or second CMR)
cardiovascular events
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Myocardial Infarction With Non-Obstructive Coronary Artery
RecruitingObservational study
Coronary Microvascular Dysfunction Assessments in Myocardial Infarction With Non-Obstructive Coronary Arteries
Myocardial Infarction, Coronary Microvascular Dysfunction
RecruitingPhase 2
Stratified Medicine of Eplerenone in Acute Myocardial Infarction or Injury and no Obstructive Coronary Arteries.
Myocardial Infarction, Acute, Myocardial Infarction With Nonobstructive Coronary Arteries
RecruitingObservational study
Acute Myocardial Infarction: Prognostic and Therapeutic Evaluation
Acute Coronary Syndrome, Myocardium; Injury
RecruitingObservational study
Barts-MINOCA Registry
Myocardial Infarction, Gender
Active, not recruitingObservational study
Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance
Acute Coronary Syndromes (ACS), Chronic Coronary Syndrome
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.
Verena C Wilzeck, MD contact
Robert Manka, Prof. MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMR in people with Myocardial Infarction With Non-Obstructive Coronary Artery and Myocarditis Acute, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 5 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 21 Mar 2024. 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 Switzerland. 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?
Contact Robert Manka, Prof., MD (+41442551251, robert.manka@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial perfusion reserve index (time frame: within 10 days and after 3 months after index event). 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 21 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.