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Completed

NCT Number: NCT02783963

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Prevalence of plaque disruption

    Time frame: 1 day

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

  2. Prevalence of myocardial injury

    Time frame: 1 week

    Prevalence of late gadolinium enhancement and myocardial edema in CMR

Secondary outcomes

  1. Prevalence of plaque vulnerability

    Time frame: 1 day

    Prevalence of plaque vulnerability (including thin-cap fibroatheroma, superficial microcalcification, macrophage infiltration, and microchannel formation) in OCT

  2. Correlation of OCT plaque characteristics and CMR findings

    Time frame: 1 week

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

    Time frame: 1 week

  4. Quantification of CAD in coronary angiography

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Warsaw, Poland

Other

Registry information

Official study title

Optical Coherence Tomography in Patients With Acute Myocardial Infarction and Nonobstructive Coronary Artery Disease: OCT and CMR Study (SOFT-MI)

Acronym: SOFT-MI

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 26, 2016
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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