Status:
COMPLETED
Optical Coherence Tomography in Patients With Acute Myocardial Infarction and Nonobstructive Coronary Artery Disease
Lead Sponsor:
National Institute of Cardiology, Warsaw, Poland
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT02783963
Start Date
April 1 2015
End Date
July 1 2017
Last Update
November 24 2017
Active Locations (1)
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1
Institute of Cardiology
Warsaw, Poland, 04-628