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)

Sponsors

Lead Sponsor: Xiamen Cardiovascular Hospital, Xiamen University

Source Xiamen Cardiovascular Hospital, Xiamen University
Brief 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.

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.

Overall Status Recruiting
Start Date 2021-02-11
Completion Date 2023-05-01
Primary Completion Date 2023-02-28
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
all-cause mortality 12 months
Secondary Outcome
Measure Time Frame
Major adverse cardiovascular and cerebrovascular events (MACE) 12 months
Stroke 12 months
contrast-induced nephropathy(CIN) 12 months
Dosimetry calculation Immediately after PCI
Enrollment 1700
Condition
Intervention

Intervention Type: Procedure

Intervention Name: In-hospital staged PCI

Description: After revascularization of the culprit lesion, all significant non-culprit vessel will be complete revascularzed during index the index procedure (7±3 day).

Arm Group Label: In-hospital staged PCI

Other Name: Percutaneous coronary intervention

Intervention Type: Procedure

Intervention Name: Out-hospital staged PCI

Description: 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.

Arm Group Label: Out-hospital staged PCI

Other Name: Percutaneous coronary intervention

Eligibility

Criteria:

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.

Gender:

All

Gender Based:

Yes

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Yan Wang, Dr Principal Investigator Clinical Trial Center of Xiamen Cardiovascular Hospital
Overall Contact

Last Name: Xiang Chen, Dr

Phone: 18033997788

Email: [email protected]

Location
Facility: Status: Contact: Xiamen Cardiovascular Hospital Xiamen University Yan Wang, Ph.D [email protected]
Location Countries

China

Verification Date

2021-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Xiamen Cardiovascular Hospital, Xiamen University

Investigator Full Name: Yan Wang

Investigator Title: Prof

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: In-hospital staged PCI

Type: Active Comparator

Description: 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.

Label: Out-hospital staged PCI

Type: Experimental

Description: 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 Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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