Institute of Cardiology
Warsaw, 04-628, Poland
NCT Number: NCT02783963
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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All sexes
Interventional
Not applicable
Warsaw, 04-628, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 day
Prevalence of plaque disruption (including plaque rupture, plaque erosion, intracoronary thrombus) in OCT
Time frame: 1 week
Prevalence of late gadolinium enhancement and myocardial edema in CMR
Time frame: 1 day
Prevalence of plaque vulnerability (including thin-cap fibroatheroma, superficial microcalcification, macrophage infiltration, and microchannel formation) in OCT
Time frame: 1 week
Time frame: 1 week
Time frame: 1 day
National Institute of Cardiology, Warsaw, Poland
Other
Optical Coherence Tomography in Patients With Acute Myocardial Infarction and Nonobstructive Coronary Artery Disease: OCT and CMR Study (SOFT-MI)
Acronym: SOFT-MI
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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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