CMR or Angiography for FFR-guided Revascularisation

NCT ID: NCT03408912

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-26
• Study Completion Date: 2024-12-31

Brief Summary

Around 50% of patients that present with ST Elevation Myocardial Infarction (STEMI) have residual disease in the non-culprit lesions. If the residual disease should be treated, what should guide intervention? Fractional Flow Reserve (FFR) has been proposed as a guide for intervention, however new developments in cardiovascular magnetic resonance (CMR) allows for non-invasive FFR measurements.

If FFR from CMR can predict physiological significant stenosis as good as FFR from invasive angiography, unnecessary invasive producers can be avoided in patients with STEMI.

Detailed Description

Early reperfusion of epicardial coronaries is essential for salvage of ischemic myocardium, reducing both morbidity and mortality in patients with ST elevation myocardial infarction (STEMI). Current European Society of Cardiology guidelines recommend percutaneous coronary intervention (PCI) of the infarct related artery (IRA) for patients presenting with STEMI, with residual disease initially being treated conservatively. Large meta-analyses of observational studies have shown that PCI of the IRA only results in a reduced mortality compared to full revascularization in patients with STEMI and simultaneous multivessel disease. However, recent small randomized controlled trials indicate that full revascularization reduces morbidity, but have been underpowered to show any reduction in mortality. Furthermore, physiological guidance of coronary intervention by fractional flow reserve (FFR) reduces mortality compared to angiography guided PCI in both stable angina and non-STEMI (NSTEMI). However, if performing full revascularization guided by FFR in patients with STEMI improves clinical outcome, compared to initial conservative approach is not known.

Assessment of myocardial perfusion in rest and during pharmacological stress is widely used for non-invasive diagnosis of myocardial ischemia, where cardiovascular magnetic resonance (CMR) has a high diagnostic accuracy. Newly developed first pass perfusion imaging with cardiovascular magnetic resonance (CMR) allows for quantification of myocardial perfusion, and CMR derived FFR. However, it is currently not known if FFR from CMR and invasive angiography correlate with each other. If FFR from CMR can predict physiological significant stenosis as good as FFR from invasive angiography, unnecessary invasive producers can be avoided in patients with STEMI.

Conditions

STEMI

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CMR and angiography FFR

Patients will undergo both CMR and angiography to acquired FFR.

Group Type: OTHER

FFR

Intervention Type: DIAGNOSTIC_TEST

FFR from CMR compared to invasive FFR

Interventions

FFR

FFR from CMR compared to invasive FFR

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients included in the active arm of FULL REVASC, that has not undergone invasive FFR, and give written informed consent.

Exclusion Criteria

• Asthma/Chronic Obstructive Pulmonary Disease, systolic blood pressure under 90 mmHg, bradycardia (less than 45 beats/min), persistent second or third AtrioVentricular-block, Sick Sinus Syndrome, Long QT Syndrome, atrial fibrillation, severe aortic stenosis, severe heart failure (NHYA class III-IV), metallic implants, kidney failure (less than 30 ml/min/1.73 square meters body surface area), current treatment with the drugs Persantin, theophyllamin or Fevarin.

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

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Martin Ugander

MD, PhD, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Ugander, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Felix Böhm, MD, PhD

Role: STUDY_CHAIR

Karolinska Institutet

Locations

Karolinska University Hospital

Stockholm, Solna, Sweden

Countries

Sweden

Other Identifiers

2017/1821-31

Identifier Type: -

Identifier Source: org_study_id