Clinical trial NCT03479593: Culprit Lesions in NSTEMI With Multi Vessel Disease (NSTEMI-CULPRIT)
Official title: Identification of Culprit Lesions in Non ST-elevation Myocardial Infarction and Multivessel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NSTEMI - Non-ST Segment Elevation MI
Multi Vessel Coronary Artery Disease
Keywords: NSTEMI
Culprit
Cardiac magnetic resonance
Optical Coherence Tomography
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible NSTEMI patients scheduled for CAG at one center

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age
* NSTEMI (ECG changes and/or troponin/creatine kinase myocardial band (CK-MB) rise) within 48 hours after symptom debut.
* Multivessel disease at CAG: More than one vessel with \>50% stenosis.

Exclusion Criteria:

* Known intolerance of heparin or contrast medium.
* Inability to understand information or to provide informed consent.
* estimated glomerular filtration rate (eGFR) \< 30 ml/min.
* Other reasons for troponin rise not applicable to acute myocardial infarction.
* Atrial fibrillation at admission.
* Patients with contraindication for CMR will only have OCT performed.
* Potential pregnancy
* Unstable patients requiring acute CAG and PCI

Primary outcomes:
measure: Is the PCI operator capable of identifying the culprit lesion based on ECG-changes and CAG? (CMR is the golden standard)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Positive predictive value of PCI operator identification of culprit lesion with CAG and ECG.
timeFrame: Through study completion, an average of 1 year
measure: Improvement in identification of culprit lesions evaluated by identification of an additional diagnostic value of OCT compared to CAG/ECG
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, University of Copenhagen
name: Thomas Engstrøm, DMSCi, PhD
role: PRINCIPAL_INVESTIGATOR
References: