Clinical trial NCT04918030: STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease（STAGED）
Official title: STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease （STAGED）
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: STEMI
Multi Vessel Coronary Artery Disease
Percutaneous Coronary Intervention
Lead sponsor: Xiamen Cardiovascular Hospital, Xiamen University
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: all-cause mortality
timeFrame: 12 months
Secondary outcomes:
measure: Major adverse cardiovascular and cerebrovascular events (MACE)
timeFrame: 12 months
measure: Rate of Stroke
timeFrame: 12 months
measure: Rate of contrast-induced nephropathy（CIN）
timeFrame: 12 months
measure: Dosimetry calculation（The amount of X-ray exposure shown by the DSA）
timeFrame: Immediately after PCI
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital Xiamen University
state: Fujian
Study officials:
affiliation: Clinical Trial Center of Xiamen Cardiovascular Hospital
name: Yan Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References: