Myocardial Infarction with Nonobstructive Coronary ArteriesSMINC-3NCT05426408
Stockholm Myocardial Infarction with Nonobstructive Coronaries Study 3
A study testing Cardiac magnetic resonance imaging to study coronary microvascular dysfunction in people with Myocardial Infarction with Nonobstructive Coronary Arteries, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The present pilot study will investigate the prevalence of CMD in an unselected cohort of patients with the working diagnosis MINOCA and to study if the diagnostic yield can be improved by adding adenosine to the CMR investigation. Patient will be their own controls. Read more about this study
- Who is it for?
- Ages 35 to 79 years
- Conditions the study is for
- Myocardial Infarction with Nonobstructive Coronary Arteries
- What is being tested?
- Cardiac magnetic resonance imaging to study coronary microvascular dysfunction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2022to 30 Jun 2026
- 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 35 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a suspected diagnosis of MINOCA or takotsubo syndrome with coronary angiography without diameter stenosis ≥50%
- age 35-80 years
- reading and writing proficiency in Swedish
Who cannot join
- Claustrofobia
- Arrythmia and/or pacemaker (atrial fibrillation and AV-block I- III)
- Asthma or severe chronic obstructive lung disease
- eGFR < 30 ml/min
- spontaneous coronary artery dissection
- acute pulmonary embolism
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- acute myocardial infarction type 2
- cardiomyopathy other than takotsubo syndrome
- a previous myocardial infarction due to CAD
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Per Tornvall
Stockholm, 11551
Per Tornvall, +46722180560, per.tornvall@ki.se
About this study
Official title: Stockholm Myocardial Infarction with Nonobstructive Coronaries Study 3 - Pilot Study of Prevalence of Coronary Microvascular Dysfunction in Myocardial Infarction with Nonobstructive Coronary Arteries
The present pilot study will investigate the prevalence of CMD in an unselected cohort of patients with the working diagnosis MINOCA and to study if the diagnostic yield can be improved by adding adenosine to the CMR investigation. Patient will be their own controls.
- Being tested
- Cardiac magnetic resonance imaging to study coronary microvascular dysfunction
- Medical subject headings
- MINOCA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonance imaging to study coronary microvascular dysfunctionDiagnostic test
Myocardial perfusion mapping will be investigated after administration of adenosine
| Study group | Role | What they receive |
|---|---|---|
| Patients with MINOCA undergoing CMR | Other | Patients will be their own controls Receives: Diagnostic Test: Cardiac magnetic resonance imaging to study coronary microvascular dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
To increase the diagnostic yield of CMR imaging in MINOCA as a working diagnosis
Measured: Through investigation completion, usually 2 hours
Secondary outcomes (3)
Prevalence of CMD in MINOCA
To determine the proportion of patients with the working diagnosis of MINOCA who have CMD.
Measured: Through investigation completion, usually 2 hours
Prevalence of CMD in different final MINOCA diagnoses
To study the proportions of CMD in patients with a CMR imaging diagnosis of myocardial infarction, Takotsubo, respectively myocarditis and compare them with the results from a healthy control group
Measured: Through investigation completion, usually 2 hours
Angina pectoris
To investigate the occurrence of angina pectoris before inclusion and after 3 months and relate it to CMD
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Nov 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (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 Nonobstructive Coronary ArteriesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will be their own controls
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Per Tornvall, Karolinska Institutet
- Investigators
- Per Tornvall, MD, Principal investigator, Karolinska Instítutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426408
- Sponsor's protocol ID
- SMINC-3
- Acronym
- SMINC-3
- Status last verified
- Oct 2024
- First submitted
- 10 Jun 2022
- Last updated
- 10 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stockholm Myocardial Infarction with Nonobstructive Coronaries Study 3 - Pilot Study of Prevalence of Coronary Microvascular Dysfunction in Myocardial Infarction with Nonobstructive Coronary Arteries
- ClinicalTrials.gov ID
- NCT05426408
- Acronym / sponsor ID
- SMINC-3 / SMINC-3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Jun 2022 (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 present pilot study will investigate the prevalence of CMD in an unselected cohort of patients with the working diagnosis MINOCA and to study if the diagnostic yield can be improved by adding adenosine to the CMR investigation. Patient will be their own controls.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will be their own controls
| Arm | Type | Receives |
|---|---|---|
| Patients with MINOCA undergoing CMR | Other | Diagnostic Test: Cardiac magnetic resonance imaging to study coronary microvascular dysfunctionPatients will be their own controls |
Who may qualify
- Ages
- 35 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a suspected diagnosis of MINOCA or takotsubo syndrome with coronary angiography without diameter stenosis ≥50%
- age 35-80 years
- reading and writing proficiency in Swedish
Key exclusion criteria (9 listed)
- Claustrofobia
- Arrythmia and/or pacemaker (atrial fibrillation and AV-block I- III)
- Asthma or severe chronic obstructive lung disease
- eGFR < 30 ml/min
- spontaneous coronary artery dissection
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 |
|---|---|---|
| Cardiac magnetic resonance imaging to study coronary microvascular dysfunctionMyocardial perfusion mapping will be investigated after administration of adenosine | Diagnostic test | Patients with MINOCA undergoing CMR |
Primary outcome
Diagnostic yield
Time frame: Through investigation completion, usually 2 hours
To increase the diagnostic yield of CMR imaging in MINOCA as a working diagnosis
3 secondary outcomes
Prevalence of CMD in MINOCA
Time frame: Through investigation completion, usually 2 hours
Prevalence of CMD in different final MINOCA diagnoses
Time frame: Through investigation completion, usually 2 hours
Angina pectoris
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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. This study is not recruiting at the moment.
Per Tornvall, MD principal investigator
Karolinska Instítutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac magnetic resonance imaging to study coronary microvascular dysfunction in people with Myocardial Infarction with Nonobstructive Coronary Arteries, run by Karolinska Institutet at 1 site in Sweden.
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 9 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 10 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 Sweden. 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 Per Tornvall, MD (+468616100, per.tornvall@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: Through investigation completion, usually 2 hours). 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 10 Mar 2025.