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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary: 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.
Sponsor: Institute of Cardiology, Warsaw, Poland

Current Primary Outcome:

  • Prevalence of plaque disruption [ Time Frame: 1 day ]
    Prevalence of plaque disruption (including plaque rupture, plaque erosion, intracoronary thrombus) in OCT
  • Prevalence of myocardial injury [ Time Frame: 1 week ]
    Prevalence of late gadolinium enhancement and myocardial edema in CMR


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • Correlation of OCT plaque characteristics and CMR findings [ Time Frame: 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) [ Time Frame: 1 week ]
  • Quantification of CAD in coronary angiography [ Time Frame: 1 day ]


Original Secondary Outcome: Same as current

Information By: Institute of Cardiology, Warsaw, Poland

Dates:
Date Received: May 23, 2016
Date Started: April 2015
Date Completion: April 2017
Last Updated: May 23, 2016
Last Verified: May 2016