Optical Coherence Tomography in Patients With Acute Myocardial Infarction and Nonobstructive Coronary Artery Disease

NCT02783963 | Completed DMC

• 1 other identifier: IP2014 034073
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the prevalence and morphological features of coronary plaques by means of OCT in patients with acute myocardial infarction but without any significant coronary stenosis at coronary angiography. In addition, cardiac magnetic resonance imaging (CMR) will be performed to assess the prevalence, location, and pattern of myocardial injury as well as other concomitant findings. As a secondary analysis, the association between the distribution and characteristics of coronary plaques detected on OCT and myocardial injury shown by CMR will be evaluated. In addition, a post-hoc survey regarding the potential modification of the interventional treatment approach based on OCT analysis will be conducted.

Conditions

Myocardial Infarction

Keywords

Coronary Artery Disease; Coronary Thrombosis; Coronary Stenosis; Tomography, Optical Coherence; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

• Prevalence of plaque disruption

  Prevalence of plaque disruption (including plaque rupture, plaque erosion, intracoronary thrombus) in OCT

  1 day

• Prevalence of myocardial injury

  Prevalence of late gadolinium enhancement and myocardial edema in CMR

  1 week

Secondary Outcomes (4)

• Prevalence of plaque vulnerability

  1 day

• Correlation of OCT plaque characteristics and CMR findings

  1 week

• Impact of OCT analysis on modification of interventional cardiology approach as well as medical treatment compared with coronary angiography alone (post-hoc analysis)

  1 week

• Quantification of CAD in coronary angiography

  1 day

Study Arms (1)

MI with nonobstructive CAD at coronary angiography

OTHER

MI with nonobstructive CAD investigated by means of OCT and CMR

Device: OCT and CMR imaging

Interventions

OCT and CMR imaging DEVICE

OCT: Imaging for the presence and vulnerability of coronary plaque as well as plaque disruption. CMR: Imaging for identification of myocardial injury (late gadolinium enhancement and myocardial edema) as well as other concomitant findings.

MI with nonobstructive CAD at coronary angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of myocardial infarction: elevation of troponin to above the laboratory upper limit of normal (ULN) or new ST segment elevation of ≥1mm on 2 contiguous ECG leads or new left bundle branch block
• Symptoms of ischaemia (chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms with concomitant ST-segment depression, T wave inversion or transient ST-segment elevation)
• Delivery of an informed consent and compliance with study protocol
• Age ≥ 18 years

You may not qualify if:

• Prior diagnosis of obstructive CAD (including history of percutaneous coronary intervention or coronary artery bypass grafting)
• Stenosis \>50% of any coronary vessel on invasive angiography
• Contraindication to OCT in the opinion of the treating physician
• Use of vasospastic agents
• Alternate causes of myocardial injury/ischaemia (severe anaemia, hypertensive crisis, acute heart failure, cardiac trauma, pulmonary embolism, etc.)
• Severe renal failure (eGFR\<30)
• Pregnancy

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead

Study Sites (1)

Institute of Cardiology

Warsaw, 04-628, Poland

Location

Related Publications (1)

• Opolski MP, Spiewak M, Marczak M, Debski A, Knaapen P, Schumacher SP, Staruch AD, Grodecki K, Chmielak Z, Lazarczyk H, Kukula K, Tyczynski P, Pregowski J, Dabrowski M, Kadziela J, Florczak E, Skrobisz A, Witkowski A. Mechanisms of Myocardial Infarction in Patients With Nonobstructive Coronary Artery Disease: Results From the Optical Coherence Tomography Study. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2210-2221. doi: 10.1016/j.jcmg.2018.08.022. Epub 2018 Oct 17.

  PMID: 30343070 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease; Coronary Thrombosis; Coronary Stenosis

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Thrombosis; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Maksymilian P. Opolski, MD, PhD

  National Institute of Cardiology, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: May 26, 2016
• Study Start: April 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

PL (1)