Non-ST Elevation Myocardial InfarctionKaPSICA-CMRNCT06566625
Cardiac MRI Prior to Invasive Coronary Angiography in Patients With Suspected Non-ST-Elevation Myocardial Infarction
An observational study of Non-ST Elevation Myocardial Infarction and Acute Coronary Syndrome, run by Region Stockholm at 1 site in Sweden.
Trial summary
Patients with a suspected myocardial infarction are subdivided into ST-elevation and non-ST-elevation myocardial infarctions (STEMI and NSTEMI, respectively) using ECG. While patients with STEMI are urgently referred to a cath lab, patients with NSTEMI usually undergo a planned invasive coronary angiography (ICA)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-ST Elevation Myocardial Infarction, Acute Coronary Syndrome
- What is being tested?
- Cardiac MRI (CMR) examination
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 17 Jul 2024to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients who present with suspected NSTEMI and have a planned invasive coronary angiography
Who may be able to join
- ≥18 years of age Suspected NSTEMI (signs and symptoms suggest of ACS with initial ECG showing no ST-elevation)
- Planned ICA where CMR can be performed without delaying ICA
- Able to provide written informed consent
Who cannot join
- Contraindications for CMR examination with gadolinium contrast (claustrophobia, eGFR <30ml/min/1.73m2, contrast allergy, and non-MRI compatible implants)
- Arrythmias which hinder CMR examination
- Previous CABG
- Hemodynamic instability
- Myocardial infarction <6 months prior to inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, Sweden, 171 64
Daniel F Andersson, M.D., 46+735958647, daniel.f.andersson@ki.se
Marcus E Carlsson, Professor, marcus.carlsson@ki.se
About this study
Official title: The Karolinska Pilot Study for Cardiac Magnetic Resonance Imaging Prior to Invasive Coronary Angiography in Patients With Suspected Non-ST-Elevation Myocardial Infarction
Patients with a suspected myocardial infarction are subdivided into ST-elevation and non-ST-elevation myocardial infarctions (STEMI and NSTEMI, respectively) using ECG. While patients with STEMI are urgently referred to a cath lab, patients with NSTEMI usually undergo a planned invasive coronary angiography (ICA) anywhere from 24-72 hours after arriving to the hospital. When an invasive coronary angiography can not explain the cause of a myocardial infarction, an MRI of the heart (a CMR) is often done as a follow-up investigation.
A growing body of evidence suggests that performing a CMR before the planned ICA can provide an accurate diagnosis and defer the need for an ICA in many of these patients with NSTEMI.
Read the detailed description
KaPSICA-CMR is an observational pilot study at the Karolinska University Hospital which aims to validate, in a Swedish healthcare setting, the potentials of a CMR-first approach in patients with suspected NSTEMI. We plan to include 150 patients, both with (n=50) and without (n=100) previous myocardial infarction. In addition to a standard clinical CMR protocol, the study will test novel CMR techniques such as magnetic resonance angiography and magnetic resonance fingerprinting sequences in this cohort. Patients will be recruited at both the Solna- and Huddinge sites of the hospital and include patients referred to ICA from the Visby- and Södertälje hospitals. The findings on the CMR will be blinded to treating physicians, with exceptions for unexpected adverse findings. In the event that a CMR would be indicated in line with clinical practice, the CMR findings are unblinded.
- Being tested
- Cardiac MRI (CMR) examination
- Keywords
- CMR, MRI, Cardiac MRI, Cardiac Magnetic Resonance, Cardiac Magnetic Resonance imaging, AMI, ACS, Acute Coronary Syndrome, NSTEMI, Non-STEMI, ICA, Invasive Coronary Angiography, Coronary Angiography, T1, T2, Magnetic Resonance Fingerprinting, Native T1, Native T2, Magnetic Resonance Angiography
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRI (CMR) examinationDiagnostic test
Also called cmr, cardiac mri, cmr angiography, cmr fingerprinting
An MRI examination of the heart (CMR) is presently performed as a follow-up examination in patients where an invasive coronary angiography (ICA) shows no obstructive findings. The intervention in this study is characterized by having the CMR performed before, rather than after, the ICA.
In addition, this study will implement some novel CMR sequences which have not been previously tested in this patient cohort:
- CMR Angiography (imaging the coronary arteries using MRI)
- CMR Fingerprinting (sequences which perform T1 and T2 mapping simultaneously)
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort | Inclusion criteria:
≥18 years of age Suspected NSTEMI (signs and symptoms suggest of ACS with initial ECG showing no ST-elevation) Planned ICA where CMR can be performed without delaying ICA Able to provide written informed consent
Exclusion criteria:
Contraindications for CMR examination with gadolinium contrast (claustrophobia, eGFR <30ml/min/1.73m2, contrast allergy, and non-MRI compatible implants) Arrythmias which hinder CMR examination Previous CABG Hemodynamic instability Myocardial infarction <6 months prior to inclusion Receives: Diagnostic Test: Cardiac MRI (CMR) examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of non-ischemic diagnosis
In cases where CMR establishes a diagnosis which is non-ischemic in nature, such as a myocarditis, an ICA can be deferred since a diagnosis has been made using CMR.
Measured: Every three months, until study completion
Rate of IRA territory reclassification
One primary outcome measurement will be to what extent a CMR examination can reclassify the IRA (infarct-related artery) territory established on ICA, by designating a new IRA based on the area of infarction on CMR using the 17-segment model of the American Heart Association and magnetic resonance angiography
Measured: Every three months, until study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start17 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- The Swedish Research Council
- Responsible party
- Sponsor
- Investigators
- Marcus E Carlsson, Professor, Principal investigator, Karolinska Insitutet and Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566625
- Sponsor's protocol ID
- 2024-02286-01
- Other IDs
- Dnr 2024-02286-01
- Acronym
- KaPSICA-CMR
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Karolinska Pilot Study for Cardiac Magnetic Resonance Imaging Prior to Invasive Coronary Angiography in Patients With Suspected Non-ST-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06566625
- Acronym / sponsor ID
- KaPSICA-CMR / 2024-02286-01
- Keywords
- CMR, MRI, Cardiac MRI, Cardiac Magnetic Resonance, Cardiac Magnetic Resonance imaging, AMI, ACS, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- The Swedish Research Council
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Aug 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.
Patients with a suspected myocardial infarction are subdivided into ST-elevation and non-ST-elevation myocardial infarctions (STEMI and NSTEMI, respectively) using ECG. While patients with STEMI are urgently referred to a cath lab, patients with NSTEMI usually undergo a planned invasive coronary angiography (ICA) anywhere from 24-72 hours after arriving to the hospital. When an invasive coronary angiography can not explain the cause of a myocardial infarction, an MRI of the heart (a CMR) is often done as a follow-up investigation.
A growing body of evidence suggests that performing a CMR before the planned ICA can provide an accurate diagnosis and defer the need for an ICA in many of these patients with NSTEMI.
Detailed description
KaPSICA-CMR is an observational pilot study at the Karolinska University Hospital which aims to validate, in a Swedish healthcare setting, the potentials of a CMR-first approach in patients with suspected NSTEMI. We plan to include 150 patients, both with (n=50) and without (n=100) previous myocardial infarction. In addition to a standard clinical CMR protocol, the study will test novel CMR techniques such as magnetic resonance angiography and magnetic resonance fingerprinting sequences in this cohort. Patients will be recruited at both the Solna- and Huddinge sites of the hospital and include patients referred to ICA from the Visby- and Södertälje hospitals. The findings on the CMR will be blinded to treating physicians, with exceptions for unexpected adverse findings. In the event that a CMR would be indicated in line with clinical practice, the CMR findings are unblinded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational cohort | – | Diagnostic Test: Cardiac MRI (CMR) examinationInclusion criteria: ≥18 years of age Suspected NSTEMI (signs and symptoms suggest of ACS with initial ECG showing no ST-elevation) Planned ICA where CMR can be performed without delaying ICA Able to provide written informed consent Exclusion criteria: Contraindications for CMR examination with gadolinium contrast (claustrophobia, eGFR <30ml/min/1.73m2, contrast allergy, and non-MRI compatible implants) Arrythmias which hinder CMR examination Previous CABG Hemodynamic instability Myocardial infarction <6 months prior to inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present with suspected NSTEMI and have a planned invasive coronary angiography
Key inclusion criteria (3 listed)
- ≥18 years of age Suspected NSTEMI (signs and symptoms suggest of ACS with initial ECG showing no ST-elevation)
- Planned ICA where CMR can be performed without delaying ICA
- Able to provide written informed consent
Key exclusion criteria (5 listed)
- Contraindications for CMR examination with gadolinium contrast (claustrophobia, eGFR <30ml/min/1.73m2, contrast allergy, and non-MRI compatible implants)
- Arrythmias which hinder CMR examination
- Previous CABG
- Hemodynamic instability
- Myocardial infarction <6 months prior to inclusion
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 MRI (CMR) examinationAlso: cmr, cardiac mri, cmr angiography, cmr fingerprintingAn MRI examination of the heart (CMR) is presently performed as a follow-up examination in patients where an invasive coronary angiography (ICA) shows no obstructive findings. The intervention in this study is characterized by having the CMR performed before, rather than after, the ICA. In addition, this study will implement some novel CMR sequences which have not been previously tested in this patient cohort: * CMR Angiography (imaging the coronary arteries using MRI) * CMR Fingerprinting (sequences which perform T1 and T2 mapping simultaneously) | Diagnostic test | Observational cohort |
Primary outcome
Rate of non-ischemic diagnosis
Time frame: Every three months, until study completion
In cases where CMR establishes a diagnosis which is non-ischemic in nature, such as a myocarditis, an ICA can be deferred since a diagnosis has been made using CMR.
Rate of IRA territory reclassification
Time frame: Every three months, until study completion
One primary outcome measurement will be to what extent a CMR examination can reclassify the IRA (infarct-related artery) territory established on ICA, by designating a new IRA based on the area of infarction on CMR using the 17-segment model of the American Heart Association and magnetic resonance angiography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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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.
Marcus E Carlsson, Professor principal investigator
Karolinska Insitutet and Karolinska University Hospital
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 Non-ST Elevation Myocardial Infarction and Acute Coronary Syndrome, run by Region Stockholm 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 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel F Andersson, M.D. (+46 702319573, daniel.f.andersson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of non-ischemic diagnosis (time frame: Every three months, until study completion). 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 12 Aug 2026.