The INTERCLIMA (Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome) is a multi-center, prospective, randomized trial of optical coherence tomography (OCT)-based versus physiology-based (i.e. fractional flow reserve\[FFR\]/instantaneous Wave-Free Ratio\[iFR\]/resting full-cycle ratio\[RFR\]) treatment of intermediate (40-70% diameter stenosis), non-culprit coronary lesions in acute coronary syndrome (ACS) patients undergoing coronary angiography. About 1420 patients with ACS will be randomized into the study at approximately 40 sites worldwide.
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:
* Age of at least 18 years.
* Diagnosis of acute coronary syndrome.
* Single or multiple intermediate lesions in intervention-naïve major coronary segments (diameter ≥2.5 mm) determining a 40-70% diameter stenosis by visual assessment with no other significant stenosis (\>70%) in the same vessel.
* Patient informed of the nature of the study, agreeing to it, and providing written informed consent as approved by the Ethics Committee of the respective clinical study site.
* Life expectancy \>3 years.
Exclusion criteria:
* Female with childbearing potential or lactating.
* Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl).
* Advanced heart failure (NYHA III-IV)
* Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time.
* Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial.
* Coronary anatomy preventing complete imaging of the segment of interest (including at least 5 mm at both stenosis edges).
* Lesions located in the left main coronary artery
* Diffusely diseased coronary artery segment or presence of ≥1 significant untreated non-culprit lesions (preventing correct adverse event attribution) in the coronary arteries.
* Prior myocardial infarction or coronary artery bypass graft \[CABG\] or PCI revascularization in the target coronary vessel.
* Coronary anatomy unsuitable for PCI.
* Comorbidities that might interfere with com…
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
Number of patients with cardiac death or non-fatal spontaneous target-vessel myocardial infarction
Timeframe: 3 years
Trial details
NCT IDNCT05027984
SponsorCentro per la Lotta Contro l'Infarto - Fondazione Onlus