Clinical trial NCT06566625: Cardiac MRI Prior to Invasive Coronary Angiography in Patients With Suspected Non-ST-Elevation Myocardial Infarction
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2024-08-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present with suspected NSTEMI and have a planned invasive coronary angiography

Brief summary: Patients with a suspected myocardial infarction are subdivided into ST-elevation and non-ST-elevation myocardial infarctions (STEMI and NSTEMI, respectively) using an 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 on including 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of non-ischemic diagnosis
timeFrame: Every three months, until study completion
measure: Rate of IRA territory reclassification
timeFrame: Every three months, until study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Insitutet and Karolinska University Hospital
name: Marcus E Carlsson, Professor
role: PRINCIPAL_INVESTIGATOR
References: