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NCT07646977
CORonary Thrombus Modification to Prevent MIcrovascular Damage in Patients With ST-segment Elevation Myocardial Infarction (The CORMI Trial)
Conditions: ST Elevation Myocardial Infarction, Coronary Microvascular Dysfunction, Percutaneous Coronary Intervention
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Odense University Hospital
Location: Odense University Hospital Odense
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.
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
Source: ClinicalTrials.gov (NCT07646977). StuddyBuddy aggregates publicly available trial information.