ClinicalTrials.gg
RecruitingNCT06566625KaPSICA-CMRUpdated Aug 12, 2026

Cardiac MRI Prior to Invasive Coronary Angiography in Patients With Suspected Non-ST-Elevation Myocardial Infarction

An observational study in Non-ST Elevation Myocardial Infarction and Acute Coronary Syndrome, sponsored by Region Stockholm. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Region Stockholm · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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) 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.

02

Conditions studied

  • Non-ST Elevation Myocardial Infarction
  • Acute Coronary Syndrome

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
03

In context

Non-ST Elevated Myocardial Infarction

284 studies on the registry are indexed under Non-ST Elevated Myocardial Infarction; 52 are open to participants now.

This study's planned enrollment of 150 is below the median of 525 across 130 observational studies indexed under Non-ST Elevated Myocardial Infarction.

Browse Non-ST Elevated Myocardial Infarction studies →

Lead sponsor

Region Stockholm is the lead sponsor of 121 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who present with suspected NSTEMI and have a planned invasive coronary angiography

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥18 years of age Suspected NSTEMI (signs and symptoms suggest of ACS with initial showing no ST-elevation)
  • Planned ICA where CMR can be performed without delaying ICA
  • Able to provide written

Exclusion criteria

Exclusion Criteria:

  • for CMR examination with gadolinium contrast (claustrophobia, \<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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Diagnostic Test: Cardiac MRI (CMR) examination

Interventions

  • Diagnostic testCardiac MRI (CMR) examination

    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)

    Also known as: cmr, cardiac mri, cmr angiography, cmr fingerprinting, fingerprinting, t1 mapping, t2 mapping

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Every three months, until study completion

  2. 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

    Time frame: Every three months, until study completion

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Dec 2026, 29 months after the start.

Of 54 non-industry observational studies under Non-ST Elevated Myocardial Infarction, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 86. This study's planned 29 months is below that.

Counting every sponsor, half of 76 studies reached it within 32 months; a quarter within 19 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 2, 2024
First posted
Aug 22, 2024
StartActual
Jul 17, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
May 2027
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06566625
Lead sponsor
Region Stockholm
Collaborators
The Swedish Research Council
Responsible party
Sponsor
First posted
Aug 22, 2024
Start date
Jul 17, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
May 2027 (estimated)
Last update
Aug 12, 2026

Study contacts

Daniel F Andersson, M.D.
Contact
daniel.f.andersson@ki.se
+46 702319573
Marcus E Carlsson, Professor
principal investigator · Karolinska Insitutet and Karolinska University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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