About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age < 18 years or inability to provide informed consent
Life expectancy of < 12 months
Hemodynamically instability
Pregnancy or breastfeeding
Trial design
Parallel
Treatments tested in this trial
Coronary thrombus modification
Procedure/SurgeryInflation 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/SurgeryPredilation 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.
Treatment groups
Trial outcomes
Primary outcomes
Myocardial salvage index
Calculated as the ratio of undamaged myocardium at 3 months to the area-at-risk ((Area-at-risk - final infarct size)/Area-at-risk)
Secondary outcomes
CMR metrics of myocardial damage
Infarct size measured on CMR. Both the individual values and the change will be assessed.
Left ventricular volumes by CMR
Left ventricular volumes measured by CMR. Both the individual values and the change between will be assessed.
LVEF measured by CMR
Left ventricular ejection fraction measured by CMR. Both the individual values and the change between will be assessed.
MVO measured by CMR
Microvascular obstruction measured by CMR. Both the individual values and the change between will be assessed.
Sponsors and contacts
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