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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Percutaneous Coronary Intervention; STEMI; Multi Vessel Coronary Artery Disease
• Intervention / Treatment: Procedure: In-hospital staged PCI; Procedure: Out-hospital staged PCI

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 1700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Recruiting
      • Xiamen Cardiovascular Hospital Xiamen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: In-hospital staged PCI; 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.	Procedure: In-hospital staged PCI; After revascularization of the culprit lesion, all significant non-culprit vessel will be complete revascularzed during index the index procedure (7±3 day).; Other Names: Percutaneous coronary intervention
EXPERIMENTAL: Out-hospital staged PCI; 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.	Procedure: Out-hospital staged PCI; During the index procedure, patients will have treated with primary PCI the culprit lesion only. Patients will be hospitalized again after 30±15 days to undergo PCI of the other significant coronary lesions.; Other Names: Percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality	The difference in all-cause mortality will be calculated from 0 month to 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular and cerebrovascular events (MACE)	The difference in MACCE will be calculated from 1 month to 12 months.	12 months
Rate of Stroke		12 months
Rate of contrast-induced nephropathy（CIN）		12 months
Dosimetry calculation（The amount of X-ray exposure shown by the DSA）	The amount of X-ray exposure shown by the DSA	Immediately after PCI

Collaborators and Investigators

• Sponsor: Xiamen Cardiovascular Hospital, Xiamen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 11, 2021
• Primary Completion (ANTICIPATED): February 28, 2023
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 29, 2021
• First Posted (ACTUAL): June 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 29, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 2020YLK14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No