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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MI with nonobstructive CAD at coronary angiography | Other | MI with nonobstructive CAD investigated by means of OCT and CMR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of plaque vulnerability | Prevalence of plaque vulnerability (including thin-cap fibroatheroma, superficial microcalcification, macrophage infiltration, and microchannel formation) in OCT | 1 day |
| Correlation of OCT plaque characteristics and CMR findings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maksymilian P. Opolski, MD, PhD | National Institute of Cardiology, Warsaw, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Cardiology | Warsaw | 04-628 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30343070 | Derived | 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. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| D003328 | Coronary Thrombosis |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| 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 |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |