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

NCT ID: NCT06566625

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-17
• Study Completion Date: 2025-12-31

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.

Conditions

Non-ST Elevation Myocardial Infarction; Acute Coronary Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Cardiac MRI (CMR) examination

Intervention Type: 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)

Interventions

Cardiac 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)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

cmr; cardiac mri; cmr angiography; cmr fingerprinting; fingerprinting; t1 mapping; t2 mapping

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcus E Carlsson, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Insitutet and Karolinska University Hospital

Locations

Karolinska University Hospital

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Daniel F Andersson, M.D.

Role: CONTACT

daniel.f.andersson@ki.se

+46 735958647

Facility Contacts

Daniel F Andersson, M.D.

Role: primary

daniel.f.andersson@ki.se

46+735958647

Marcus E Carlsson, Professor

Role: backup

marcus.carlsson@ki.se

Other Identifiers

Dnr 2024-02286-01

Identifier Type: OTHER

Identifier Source: secondary_id

2024-02286-01

Identifier Type: -

Identifier Source: org_study_id