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

NSTEMI - Non-ST Segment Elevation MI Clinical Trial

— NS-CULPRIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03479593
• Other study ID #: H-17023377
• Status: Recruiting
• Start date: January 10, 2018
• Est. completion date: January 1, 2024

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: Kathrine Ekström, MD
• Phone: +4535452295
• Email: kathrine.ekstroem.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Is the PCI operator capable of identifying the culprit lesion based on ECG-changes and CAG? (CMR is the golden standard)	Correlation between operator identification of the culprit and CMR/OCT. The location of the culprit on CAG/ECG and OCT versus CMR will be evaluated by the chi2-test	Through study completion, an average of 1 year
Secondary	Positive predictive value of PCI operator identification of culprit lesion with CAG and ECG.	cross-tables will be used to calculate the positive predictive value Receiver-operating-characteristics will be used to compare the additional diagnostic value of OCT compared to CAG/ECG.	Through study completion, an average of 1 year
Secondary	Improvement in identification of culprit lesions evaluated by identification of an additional diagnostic value of OCT compared to CAG/ECG	Receiver-operating-characteristics will be used to compare the additional diagnostic value of OCT compared to CAG/ECG. CMR is the golden standard.	Through study completion, an average of 1 year