Optical Coherence Tomography in Patients With Acute Myocardial Infarction and Nonobstructive Coro… (NCT02783963) | Clinical Trial Compass
CompletedNot Applicable
Optical Coherence Tomography in Patients With Acute Myocardial Infarction and Nonobstructive Coronary Artery Disease
Poland38 participantsStarted 2015-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of plaque disruption
Timeframe: 1 day
2
Prevalence of myocardial injury
Timeframe: 1 week
Trial details
NCT IDNCT02783963
SponsorNational Institute of Cardiology, Warsaw, Poland