Clinical trial NCT02783963: Optical Coherence Tomography in Patients With Acute Myocardial Infarction and Nonobstructive Coronary Artery Disease
Official title: Optical Coherence Tomography in Patients With Acute Myocardial Infarction and Nonobstructive Coronary Artery Disease: OCT and CMR Study (SOFT-MI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: Coronary Artery Disease
Coronary Thrombosis
Coronary Stenosis
Tomography, Optical Coherence
Magnetic Resonance Imaging
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of plaque disruption
timeFrame: 1 day
measure: Prevalence of myocardial injury
timeFrame: 1 week
Secondary outcomes:
measure: Prevalence of plaque vulnerability
timeFrame: 1 day
measure: Correlation of OCT plaque characteristics and CMR findings
timeFrame: 1 week
measure: Impact of OCT analysis on modification of interventional cardiology approach as well as medical treatment compared with coronary angiography alone (post-hoc analysis)
timeFrame: 1 week
measure: Quantification of CAD in coronary angiography
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Cardiology
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Maksymilian P. Opolski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.