OCT Versus Angiography for Culprit Lesion Revascularization in Acute Myocardial Infarction PatiEnts (NCT06227754) | Clinical Trial Compass
RecruitingNot Applicable
OCT Versus Angiography for Culprit Lesion Revascularization in Acute Myocardial Infarction PatiEnts
South Korea1,500 participantsStarted 2024-03-25
Plain-language summary
The aim of the study is to compare clinical outcomes between optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI).
Who can participate
Age range
19 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:
* Subject must be at least 19 years of age
* Acute ST-segment elevation myocardial infarction (STEMI)
\*STEMI: ST-segment elevation ≥0.1 mV in ≥2 contiguous leads or documented newly developed left bundle-branch block1
* Primary percutaneous coronary intervention (PCI) in \< 12 h after the onset of symptoms for STEMI patients
* Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Exclusion Criteria:
* Target lesions not amenable for PCI by operators' decision
* Ostial lesions located in left main vessel or right coronary artery (left main body or distal bifurcation lesions can be enrolled by operator's discretion)
* Creatinine clearance ≤30 ml/min/1.73 m2 and not on dialysis (chronic dialysis dependent patients are eligible for enrolment regardless of creatinine clearance)
* Cardiogenic shock (Killip class IV) at presentation
* Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus
* Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
* Pregnancy or breast feeding
* Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
* Unwillingness or inability to comply …
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.
1This trial compares two imaging approaches — OCT versus standard angiography — for guiding stent placement during a heart attack; can you explain what the practical difference is between these two methods and which one you would normally use in my care?
2Since this trial is listed as 'Phase NA,' which often means it's comparing existing standard-of-care procedures rather than testing a new drug, does that change the safety profile compared to a typical early-phase drug trial, and what risks, if any, are specific to having OCT imaging during an emergency procedure like mine?
3The trial is measuring 'target vessel failure' as its main outcome — can you explain what that means in plain terms, and how long I would likely need to be followed up and monitored as part of this study?
4Given that I've just had a heart attack and time is critical, how would enrolling in this trial affect the speed or course of my emergency treatment, and is there any scenario where being in the study could delay the care I need?
5Are there standard angiography-guided stenting approaches outside of this trial that you would recommend for my specific situation, and what would help us decide whether joining this study makes sense compared to just proceeding with your usual approach?
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.