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

NCT ID: NCT02783963

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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The mechanism of myocardial infarction in patients with nonobstructive coronary artery disease remains unknown. The SOFT-MI study has been designed as a single-center, prospective observational trial to investigate the prevalence of vulnerable and disrupted plaques in patients with acute MI but without any significant coronary stenosis (defined as stenosis of \>50%) at coronary angiography. All patients will undergo coronary OCT immediately after coronary angiography. In addition, CMR will be performed within 1 week of coronary angiography to evaluate associated myocardial abnormalities as well as extracardiac findings. The study will provide insight into the mechanism of MI without obstructive coronary artery disease at coronary angiography, and may be useful in order to establish an appropriate therapeutic strategy for the secondary prevention of ischemic events.

Conditions

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Myocardial Infarction

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MI with nonobstructive CAD at coronary angiography

MI with nonobstructive CAD investigated by means of OCT and CMR

Group Type OTHER

OCT and CMR imaging

Intervention Type 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.

Interventions

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OCT and CMR imaging

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maksymilian P. Opolski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cardiology, Warsaw, Poland

Locations

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Institute of Cardiology

Warsaw, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type DERIVED
PMID: 30343070 (View on PubMed)

Other Identifiers

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IP2014 034073

Identifier Type: -

Identifier Source: org_study_id