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

NCT06566625 | Recruiting

• 2 other identifiers: 2024-02286-01Dnr 2024-02286-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Every three months, until study completion

Study Arms (1)

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

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)

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

Observational cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 171 64, Sweden

RECRUITING

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction; Acute Coronary Syndrome

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Marcus E Carlsson, Professor

  Karolinska Insitutet and Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel F Andersson, M.D.

CONTACT

+46 735958647; daniel.f.andersson@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: August 22, 2024
• Study Start: July 17, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-06

Locations

SE (1)