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CORonary Thrombus Modification to Prevent MIcrovascular Damage in Patients With ST-segment Elevation Myocardial Infarction (The CORMI Trial)

Sponsor: Odense University Hospital • ClinicalTrials.gov ID: NCT07646977

Registry updated: 2026-09-02

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Description

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.

Interventions

Coronary thrombus modification (Procedure)
Inflation of a short balloon not larger than the vessel size for 30 seconds following deflation for 30 seconds repeated a total of 4 times. Thereafter, patients will undergo standard stent implantation as per operator decision.
Standard stent implantation (Procedure)
Predilation before stent implantation will follow normal clinical guidelines, and to the discretion of the operator. patients will undergo standard stent implantation as per operator decision.

Eligibility criteria

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

Conditions

ST Elevation Myocardial Infarction Coronary Microvascular Dysfunction Percutaneous Coronary Intervention

Locations

Odense University Hospital — Odense, Denmark

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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