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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegion Stockholm

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cardiac MRI (CMR) examination

    Diagnostic test

    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)

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Observational cohort1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Stockholm

Lead sponsor

The Swedish Research Council

Collaborator