By InvitationNot Applicable

Optical Coherence Tomography in Acute Vessel Evaluation

Belgium, Denmark, Estonia3,000 participantsStarted 2025-11-23

Plain-language summary

The purpose is to investigate if a strategy of routine OCT based diagnosis and guidance of PCI improves clinical outcomes compared with a standard strategy of guidance by angiography in patients presenting with ACS

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: Clinical inclusion criteria: * NSTEMI, STEMI * Symptom duration \<12h for STEMI and \<48h for NSTEMI * Age ≥ 18yrs * Ability to provide written informed consent Angiographic inclusion criteria: * Angiographic signs of at least one possible culprit lesion. Signs including acute occlusion, partial occlusion, proximal embolus, haziness, high grade stenosis, stent thrombosis * Wire in true distal lumen Exclusion Criteria: Clinical exclusion criteria * Intravascular imaging evaluation of any lesions at index procedure * Cardiogenic shock * Sustained ventricular tachycardia or ventricular fibrillation * Planned CABG * Life expectancy \<1 year * Known severe heart failure with NYHA class equal or above III * Known ejection fraction \<30% before the admission * Known renal failure with GFR \<30 ml/min/1.73 m2 * Active bleeding or coagulopathy * Relevant allergies (contrast media, aspirin, clopidogrel, ticagrelor, everolimus) * Suspected inability to lie flat for the duration of the PCI procedure * Inability to comply with the planned follow-up program * Known or anticipated compliance problems with medical therapy Angiographic exclusion criteria * Study lesion involving the Left main coronary artery * Study lesion involving a true bifurcation lesion with a SB \>2.5mm * Severe tortuosity * Distal embolus * Isolated coronary artery spasm * Suspected spontaneous coronary artery dissection * Chronic total occlusions with treatment indication and no antegrade …

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 uses optical coherence tomography — an imaging technique I may not be familiar with — so can you explain how OCT would be used during my heart procedure and whether it changes anything about how my arteries would be treated compared to standard care?
2Since this trial is measuring a combined endpoint of major adverse cardiac events like heart attacks or death, what does that mean for how my outcomes would be tracked, and how long would I need to be followed for the study?
3The trial is enrolling by invitation only — does my specific situation with acute coronary syndrome make me a candidate to be considered, and if not, would I receive the same imaging approach outside of the trial?
4Because this trial doesn't have a traditional phase label, what is already known about using OCT guidance in ACS procedures, and is there solid evidence it helps compared to standard imaging techniques like angiography alone?
5If I were to participate, how would being in this study affect the timing or decisions made during my heart procedure, and could it in any way delay or alter the treatment I'd otherwise receive right away for my condition?

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

Combined endpoint of major adverse cardiac events (MACE)

Timeframe: 12 months

Trial details

NCT IDNCT07422688

SponsorAarhus University Hospital Skejby

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-09-01

View on ClinicalTrials.gov More Ischemic Heart Disease trials

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.