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

Percutaneous Coronary Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04918030
• Other study ID #: 2020YLK14
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: October 2022
• Source: Xiamen Cardiovascular Hospital, Xiamen University
• Contact: Xiang Chen, Dr
• Phone: 18033997788
• Email: Seanchenx[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1700
• Est. completion date: May 1, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Multi Vessel Coronary Artery Disease
• Myocardial Infarction
• Percutaneous Coronary Intervention
• ST Elevation Myocardial Infarction
• STEMI

Intervention

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).
• 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.

Locations

Country	Name	City	State
China	Xiamen Cardiovascular Hospital Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Xiamen Cardiovascular Hospital, Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality	The difference in all-cause mortality will be calculated from 0 month to 12 months.	12 months
Secondary	Major adverse cardiovascular and cerebrovascular events (MACE)	The difference in MACCE will be calculated from 1 month to 12 months.	12 months
Secondary	Rate of Stroke		12 months
Secondary	Rate of contrast-induced nephropathy(CIN)		12 months
Secondary	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