ST-elevation myocardial infarction (STEMI)
Conditions
Interventions
[Study group (distal embolic prophylaxis and microcirculatory protection strategy group)]
In addition to the usual treatment, 24 mcg of nitroprusside (4.8 mcg/ml x 5 ml) will be administered in a slow
Sponsors
Sakata Yasushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with STEMI (2) Patients who are indicated for emergency PCI (Primary PCI) as initial treatment (3) Patients with TIMI flow grade 0 or 1 on initial coronary angiography (4) De novo lesions (5) Patients with a target vessel diameter of 3 mm or greater by visual evaluation on angiography (6) Patients aged 18 years or older at the time of consent (7) Patients from whom written informed consent can, in principle, be obtained from the patient or their legally authorized representative
Exclusion criteria
Exclusion criteria: (1) Those who are not scheduled for stenting (2) In-stent restenotic lesions (3) Lesions for which excimer laser coronary angioplasty is used (4) Bifurcation lesions in which the perfusion balloon is placed over a side branch, and in which impaired blood flow in the side branch would be clinically disadvantageous. (5) Cardiogenic shock (SCAI shock classification C, D, E) (6) Patients requiring mechanical circulatory support device (IABP, ECMO, Impella) (7) Pregnant or lactating women (8) Patients with active bleeding at the time of consent (9) PCI for bypass graft vessels (10) Patients for whom nitroprusside is inappropriate (allergy, contraindication, etc.) (11) Patients scheduled to participate or already participating in another clinical trial or interventional clinical trial during the 12 months following the procedure (12) Patients expected to live less than 1 year (12 months) (13) Persons who are deemed inappropriate as research subjects by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Main study] TIMI 3 flow achievement rate at the time of final PCI angiography (The reliability of the results is confirmed by the TIMI Frame Count at the last PCI angiogram.) [OCT cohort] Incidence of irregular protrusion at final OCT after PCI | — |
Secondary
| Measure | Time frame |
|---|---|
| [Key secondary endpoint] Composite endpoint of cardiovascular death, target vessel myocardial infarction, target vessel revascularization, and heart failure hospitalization at 12 months after PCI [At the time of PCI] -TIMI flow grade at immediately after stenting -TIMI flow grade at post-dilatation -Blush grade (at last contrast) -PCI procedure time -Contrast media usage -Radiation time -Mechanical circulatory support device (IABP, ECMO, Impella) utilization -PCI procedure cost -Hospitalization costs -QCA data -Stent diameter, stent length -Peak CK / Peak CK-MB -Myocardial scintigraphy -IMR [Event rate at 12 months after PCI] -Death -Myocardial infarction -Stent thrombosis -Stroke -Systemic embolism -Target lesion revascularization -Target vessel revascularization -Non-target vessel revascularization -Emergency revascularization -All coronary revascularization procedures -Heart failure hospitalization -Ischemic cardiomyopathy (ICM) conversion -All other composite and individual endpoints as defined by ARC-2 -Bleeding by ISTH criteria -Bleeding by BARC criteria | — |
Contacts
Public ContactYohei Sotomi
The University of Osaka Graduate School of Medicine
Outcome results
None listed