STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease STAGED

  • STATUS
    Recruiting
  • End date
    May 1, 2023
  • participants needed
    1700
  • sponsor
    Xiamen Cardiovascular Hospital, Xiamen University
Updated on 14 June 2021

Summary

An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with STEMI and MVD Objectives: The present study aimed to investigate the difference in all-cause mortality after in-hospital staged PCI versus out-hospital staged PCI for ST-segment elevated myocardial infarction STEMIpatients with multi-vessel DiseaseMVD Background: In primary percutaneous coronary intervention for STEMI with MVD, complete revascularization has proved to reduce the risk of cardiovascular death and myocardial infarction. However, a strategy of nonculprit-vessel PCI with the goal of complete revascularization still not to be confirmed. Compare with in-hospital staged PCI, out-hospital PCI as a strategy of nonculprit-vessel PCI for STEMI patients with MVD might have be beneficial results.

Description

A total of 1700 subjects with STEMI who met inclusion criteria and do not have any exclusion criterion will be randomized to in-hospital staged PCI group and out-hospital staged PCI group. After successful percutaneous coronary intervention for culprit lesion, all non-culprit vessel with significant lesion defined at least 80% diameter stenosis by visual estimation and accompanied by a QFR measurement of less than or equal to 0.80 will be performed complete revascularization.

  1. Patients randomized to in-hospital staged PCI will have treated during the index procedure (73 days), after revascularization of the culprit lesion, all significant non-culprit coronary lesions.
  2. Patients randomized to out-hospital staged complete revascularization will have treated during the index procedure only the culprit lesion, and they will be hospitalized in 3015 days for complete revascularization of all significant non-culprit coronary lesions.

Details
Condition Percutaneous Coronary Intervention, Multi Vessel Coronary Artery Disease, STEMI
Treatment In-hospital staged PCI, Out-hospital staged PCI
Clinical Study IdentifierNCT04918030
SponsorXiamen Cardiovascular Hospital, Xiamen University
Last Modified on14 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Provision of informed consent prior to any study specific procedures
Established indication to PPCI according to the guidelines of American Heart Association and American College of Cardiology
Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset) with MVD after successful revascularization of the culprit artery
De novo coronary lesion
TIMI Flow 3 ( Cases with TIMI flow 2 need to perform angiographic again in 24h ensured TIMI flow 3 for enrolling case )after revascularization of the culprit artery, residual stenosis 20% and no coronary dissection greater than or equal to type C leading to (threatening) vessel closure
At least one non-culprit coronary stenosis 80% and accompanied by QFR 0.8 in a vessel with a lumen diameter 2.5

Exclusion Criteria

Age <18 yr and >80 yr
Cardiac shock, multiple organ failure, cerebral hemorrhage, severe aortic stenosis and myocardial infarction complications(cardiac rupture, ventricular septal rupture and papillary muscle rupture)
Killip classification >3, cardiognic shock, shore-infarction of culprit artery after emergency PCI in 24 hours
Previous documented allergic reaction to drug and device of this study
Planned major surgery within 6 weeks in which impact DAPT
Participation in another clinical study, interfering with this protocol Uncertain
Life expectancy < 1 year
Any condition likely to interfere with study processes including follow-up visits or increase of risk accessed by researcher
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