Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI) (NCT04968808) | Clinical Trial Compass
RecruitingNot Applicable
Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI)
South Korea1,014 participantsStarted 2021-09-06
Plain-language summary
Many patients with non-ST-segment elevation myocardial infarction (NSTEMI) have multivessel coronary artery disease (MVD), which is associated with poor clinical outcomes. However, there have been few studies regarding revascularization strategy in patients with NSTEMI and MVD. Therefore, we planned to perform prospective, open-label, randomized trial to evaluate the efficacy and safety of immediate complete revascularization (percutaneous coronary intervention \[PCI\] for both infarct-related artery \[IRA\] and non-IRA during index PCI) compared to staged PCI strategy of non-IRA (PCI for IRA followed by non-IRA PCI after several days). PCI procedure at non-IRA with diameter stenosis between 50 and 69% should be conducted with the aid of fractional flow reserve (FFR), and non-IRA with diameter stenosis ≥ 70% will be revascularized without FFR.
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
. Age ≥ 19 years old
. Non-ST-segment elevation myocardial infarction
. PCI within 72 hours after symptom development
. Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation
. Patient's or protector's agreement about study design and the risk of PCI
Exclusion criteria
. Cardiogenic shock at initial presentation or after treatment of IRA
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 is comparing different timing strategies for treating my non-culprit blocked arteries after a heart attack — can you explain what 'FFR-guided PCI' means in plain terms, and how the timing of that procedure might affect my recovery?
2Since this trial is enrolling patients with multiple blocked coronary arteries alongside their heart attack, does my specific pattern of blockages make this kind of approach worth discussing, or would standard staged treatment be a more straightforward path for me?
3The trial is measuring deaths, repeat heart attacks, and unplanned repeat procedures as its main outcomes — based on what you know about my case, which of those risks concerns you most right now, and how might participating in this study affect how those risks are managed?
4Because this is listed as 'Phase NA,' which often applies to procedure-timing or strategy studies rather than new drugs, can you help me understand what is and isn't yet known about whether one timing approach is safer or more effective than the other?
5If I were to consider this trial, what would the practical demands look like — such as extra hospital stays, additional procedures, or follow-up visits — and is that realistic given my current condition and recovery needs?
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
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization
. Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision
. Non-IRA lesion not suitable for PCI treatment by operators' decision