NCT03479593

Culprit Lesions in NSTEMI With Multi Vessel Disease (NSTEMI-CULPRIT)

Identification of Culprit Lesions in Non ST-elevation Myocardial Infarction and Multivessel Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Acute myocardial infarction owes to a plaque rupture resulting in total (STEMI) or partial occlusion (NSTEMI) of the coronary artery. In patients with a partial occlusion and multi vessel disease (MVD), identification of the lesion responsible for the current event (culprit) at the time of the examination (coronary angiogram, CAG) can be difficult. Meanwhile, identification of the culprit lesion is vital to conduct proper treatment. Furthermore, treating an artery with no plaque rupture (non-culprit), imposes a small risk for complications, which may be fatal. Precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled The purpose of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD.

Detailed description

Background Acute myocardial infarction owes to a plaque rupture resulting in total (STEMI) or partial occlusion (NSTEMI) of the coronary artery. Current guidelines in NSTEMI recommend an invasive coronary angiogram (CAG) and possible treatment with percutaneous intervention (PCI) within 2-72 hours. In NSTEMI patients and multi vessel disease (MVD), identification of the lesion responsible for the current event (culprit) at the time of the examination can be difficult. Meanwhile, identification of the culprit lesion is vital to conduct proper treatment in order to restore blood flow to the myocardium. Furthermore, treating an artery with no plaque rupture (non-culprit), imposes a small risk for complications, which may be fatal. In addition, since the symptoms relate to the culprit lesion it is currently unclear whether all stenosis or only the culprit should be treated by PCI. Today precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled. Purpose The overall objective of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD. Methods The study employs cardiac magnetic resonance (CMR), which allows detection of myocardium exposed to even brief periods of ischemia. Furthermore, Optical Coherence Tomography (OCT) which visualises the coronary artery lumen and wall. OCT allows for direct visualization of atherosclerotic plaques, presence of thrombus and atherosclerotic plaque ruptured that cannot be seen on a CAG alone. Patients will have CMR performed prior to CAG. The PCI operator determines culprit based on CAG and ECG changes alone. OCT is subsequently performed on culprit lesion(s) and stenosis ≥ 50%. Sample size calculation Assuming the culprit lesion can be correctly identified with history/angiography/ECG in 95% of cases a positive predictive value \>90% with 95% accuracy can be reached with 100 patients.

Conditions

• NSTEMI - Non-ST Segment Elevation MI
• Multi Vessel Coronary Artery Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CMR and OCT in NSTEMI patients with MVD	Lesions \>50% stenosis i patients with NSTEMI are examined by OCT. All patients will have CMR performed prior to angiography

Timeline

• Start date: 2018-01-10
• Primary completion: 2022-01-01
• Completion: 2024-01-01
• First posted: 2018-03-27
• Last updated: 2023-03-29

Locations

1 site across 1 country: Denmark