CORonary Thrombus Modification to Prevent MIcrovascular Damage in Patients With ST-segment Elevat… (NCT07646977) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
CORonary Thrombus Modification to Prevent MIcrovascular Damage in Patients With ST-segment Elevation Myocardial Infarction (The CORMI Trial)
Denmark100 participantsStarted 2026-06
Plain-language summary
The aim of this study is to evaluate the effects of coronary thrombus modification on preventing the microvascular damage associated with primary percutaneous coronary intervention (PCI), and to limit the associated myocardial damage assessed by myocardial salvage index after 3 months. Furthermore, the project will evaluate coronary microvascular damage assessed invasively using both continuous and bolus thermodilution before and after stent implantation. In addition, the project will evaluate the diagnostic ability and associations of pre-stenting invasive physiological measurement to cardiac magnetic resonance imaging measurements.
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:
* ST-elevation at the J-junction in a minimum of two contiguous ECG leads with a minimum of ≥ 0.1 mV in all leads, except for V2 and V3 (which required ≥ 0.2 for men ≥ 40 years old, ≥ 0.25 in men \< 40 years old, or ≥ 0.15 mV for all women) or new left bundle branch
* Admission to hospital within 12 hours of symptom debut
* Angiographic signs of a culprit lesion planned to be treated with primary percutaneous coronary intervention
Exclusion Criteria:
* Age \< 18 years or inability to provide informed consent
* Life expectancy of \< 12 months
* Hemodynamically instability
* Pregnancy or breastfeeding
* Known asthma or severe chronic obstructive pulmonary disease
* Expected inability to perform physiological measurements (due to severely tortuous arteries, ostial disease or very distal disease),
* CMR contraindications (estimated glomerular filtration rate \< 30 mL/min, magnetic or mechanically activated implants, or any prior metal implants, severe claustrophobia)
* Expected to or unavoidable to use thrombectomy
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 focused on modifying the coronary thrombus before stenting to protect the tiny blood vessels in the heart — can you explain how that approach might help in my specific situation compared to standard heart attack treatment?
2The trial is measuring something called the 'myocardial salvage index' as its main outcome — what does that actually tell us about how much heart muscle might be saved, and is that a meaningful goal for my case?
3The trial isn't recruiting yet — given that timing, do you think I should wait to see if I might be eligible when it opens, or would starting standard treatment now be the better path for me?
4Since this trial doesn't list a traditional phase like Phase 1 or 2, what does that mean for what's already known about the safety and potential benefit of the thrombus modification technique being studied?
5How does the focus on coronary microvascular dysfunction fit with my diagnosis — is microvascular damage something that's already a concern for me, and would that make this trial more or less relevant to discuss with my care team?
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.