Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04918030
Status:
UNKNOWN
Last Update Posted:
2022-11-01
First Post:
2021-05-24
Brief Title:
STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel DiseaseSTAGED
Sponsor:
Xiamen Cardiovascular Hospital Xiamen University
Organization:
Xiamen Cardiovascular Hospital Xiamen University
Study Overview
Official Title:
STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease STAGED
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 STEMIpatients with multi-vessel DiseaseMVD 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 080 will be performed complete revascularization
1 Patients randomized to in-hospital staged PCI will have treated during the index procedure 73 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 3015 days for complete revascularization of all significant non-culprit coronary lesions
1 Patients randomized to in-hospital staged PCI will have treated during the index procedure 73 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 3015 days for complete revascularization of all significant non-culprit coronary lesions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None