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

Primary Purpose

Myocardial Infarction

Status

Completed

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

OCT and CMR imaging

About this trial

This is an interventional diagnostic trial for Myocardial Infarction focused on measuring Coronary Artery Disease, Coronary Thrombosis, Coronary Stenosis, Tomography, Optical Coherence, Magnetic Resonance Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institute of Cardiology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MI with nonobstructive CAD at coronary angiography

Arm Description

MI with nonobstructive CAD investigated by means of OCT and CMR

Outcomes

Primary Outcome Measures

Prevalence of plaque disruption

Prevalence of plaque disruption (including plaque rupture, plaque erosion, intracoronary thrombus) in OCT

Prevalence of myocardial injury

Prevalence of late gadolinium enhancement and myocardial edema in CMR

Secondary Outcome Measures

Prevalence of plaque vulnerability

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

Impact of OCT analysis on modification of interventional cardiology approach as well as medical treatment compared with coronary angiography alone (post-hoc analysis)

Quantification of CAD in coronary angiography

Full Information

NCT ID

NCT02783963

First Posted

May 23, 2016

Last Updated

November 21, 2017

Sponsor

National Institute of Cardiology, Warsaw, Poland

1. Study Identification

Unique Protocol Identification Number

NCT02783963

Brief Title

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

Acronym

SOFT-MI

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

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Cardiology, Warsaw, Poland

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

Coronary Artery Disease, Coronary Thrombosis, Coronary Stenosis, Tomography, Optical Coherence, Magnetic Resonance Imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MI with nonobstructive CAD at coronary angiography

Arm Type

Other

Arm Description

MI with nonobstructive CAD investigated by means of OCT and CMR

Intervention Type

Device

Intervention Name(s)

OCT and CMR imaging

Intervention Description

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.

Primary Outcome Measure Information:

Title

Prevalence of plaque disruption

Description

Prevalence of plaque disruption (including plaque rupture, plaque erosion, intracoronary thrombus) in OCT

Time Frame

1 day

Title

Prevalence of myocardial injury

Description

Prevalence of late gadolinium enhancement and myocardial edema in CMR

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Prevalence of plaque vulnerability

Description

Prevalence of plaque vulnerability (including thin-cap fibroatheroma, superficial microcalcification, macrophage infiltration, and microchannel formation) in OCT

Time Frame

1 day

Title

Correlation of OCT plaque characteristics and CMR findings

Time Frame

1 week

Title

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

Title

Quantification of CAD in coronary angiography

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maksymilian P. Opolski, MD, PhD

Organizational Affiliation

National Institute of Cardiology, Warsaw, Poland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Cardiology

City

Warsaw

ZIP/Postal Code

04-628

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

30343070

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.

Results Reference

derived

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

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