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

Myocardial Infarction Clinical Trial

— SOFT-MI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783963
• Other study ID #: IP2014 034073
• Status: Completed
• Phase: N/A
• First received: May 23, 2016
• Last updated: November 21, 2017
• Start date: April 2015
• Est. completion date: July 2017

Study information

• Verified date: November 2017
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Device:
• OCT and CMR imaging
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.

Locations

Country	Name	City	State
Poland	Institute of Cardiology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of plaque disruption	Prevalence of plaque disruption (including plaque rupture, plaque erosion, intracoronary thrombus) in OCT	1 day
Primary	Prevalence of myocardial injury	Prevalence of late gadolinium enhancement and myocardial edema in CMR	1 week
Secondary	Prevalence of plaque vulnerability	Prevalence of plaque vulnerability (including thin-cap fibroatheroma, superficial microcalcification, macrophage infiltration, and microchannel formation) in OCT	1 day
Secondary	Correlation of OCT plaque characteristics and CMR findings		1 week
Secondary	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
Secondary	Quantification of CAD in coronary angiography		1 day