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

Last updated: October 29, 2022
Sponsor: Xiamen Cardiovascular Hospital, Xiamen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Chest Pain

Atherosclerosis

Treatment

N/A

Clinical Study ID

NCT04918030
2020YLK14
  • Ages 18-80
  • All Genders

Study 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 （STEMI）patients with multi-vessel Disease（MVD） 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures;
  • Established indication to PPCI according to the guidelines of American HeartAssociation and American College of Cardiology;
  • Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset) withMVD 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 ensuredTIMI flow 3 for enrolling case )after revascularization of the culprit artery,residual stenosis ≤20% and no coronary dissection greater than or equal to type Cleading to (threatening) vessel closure.
  • At least one non-culprit coronary stenosis ≥ 80% and accompanied by QFR ≤0.8 in avessel with a lumen diameter ≥2.5;

Exclusion

Exclusion Criteria:

  • Age <18 yr and >80 yr;
  • Cardiac shock, multiple organ failure, cerebral hemorrhage, severe aortic stenosis andmyocardial infarction complications(cardiac rupture, ventricular septal rupture andpapillary muscle rupture);
  • Killip classification >3, cardiognic shock, shore-infarction of culprit artery afteremergency 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 orincrease of risk accessed by researcher.

Study Design

Total Participants: 1700
Study Start date:
February 11, 2021
Estimated Completion Date:
May 01, 2023

Study 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 (7±3 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 30±15 days for complete revascularization of all significant non-culprit coronary lesions.

Connect with a study center

  • Xiamen Cardiovascular Hospital Xiamen University

    Xiamen, Fujian 361000
    China

    Active - Recruiting

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