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

NCT03479593 | Unknown

• 1 other identifier: H-17023377
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

NSTEMI; Culprit; Cardiac magnetic resonance; Optical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Positive predictive value of PCI operator identification of culprit lesion with CAG and ECG.

  Through study completion, an average of 1 year

• Improvement in identification of culprit lesions evaluated by identification of an additional diagnostic value of OCT compared to CAG/ECG

  Through study completion, an average of 1 year

Study Arms (1)

CMR and OCT in NSTEMI patients with MVD

NSTEMI patients with multi vessel disease

Diagnostic Test: CMR and OCT in NSTEMI patients with MVD

Interventions

CMR and OCT in NSTEMI patients with MVD DIAGNOSTIC_TEST

Lesions \>50% stenosis i patients with NSTEMI are examined by OCT. All patients will have CMR performed prior to angiography

CMR and OCT in NSTEMI patients with MVD

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

Eligible NSTEMI patients scheduled for CAG at one center

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Interventions

Tomography, Optical Coherence; Microvascular Density

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)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Thomas Engstrøm, DMSCi, PhD

  Rigshospitalet, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathrine Ekström, MD

CONTACT

+4535452295; kathrine.ekstroem.01@regionh.dk

Thomas Engstrøm, DMSCi, PhD

CONTACT

+4535458444; thomas.engstroem@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: March 27, 2018
• Study Start: January 10, 2018
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)