Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Location status: Recruiting
Location contact
Jun Pu
CONTACT
NCT Number: NCT05967663
It is a prospective, multicenter, randomised controlled, open-label, blinded endpoint assessment trial, to compare the strategy of immediate complete revascularisation and staged complete revascularisation in ST-segment-elevation myocardial infarction patients with multivessel coronary disease.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Shanghai, China
Location status: Recruiting
Jun Pu
CONTACT
Objectives: The purpose of this study is to investigate whether FFR guided PCI strategy for non-culprit lesions should be attempted during the index procedure or staged in ST-segment-elevation myocardial infarction patients with multivessel coronary disease.
Inclusion criteria
Exclusion criteria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In patients allocated to the immediate complete revascularisation group, PCI of the culprit lesion was attempted first and followed by all other lesions deemed to be clinically significant by the operator during the index procedure.
In the staged complete revascularisation group, only the culprit lesion was treated during the index procedure and PCI of all non-culprit lesions deemed to be clinically significant by the operator was planned at a later stage through an elective re-admission within 15-45 days after randomisation.
Time frame: At 1 year after the index procedure
The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischemia-driven revascularization, stroke or hospitalization for heart failure at 1 year after the index procedure.
Time frame: At 1 months, 6 months, 2 and 3 years after the index procedure
The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischemia-driven revascularization, stroke or hospitalization for heart failure at 1 year after the index procedure.
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
All-cause mortality (cardiovascular death, non- cardiovascular death, undetermined cause of death)
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Cardiovascular death
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Myocardial Infarction (Q-wave and non Q-wave MI)
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
TVR: Target vessel revascularization(Ischemia driven revascularization, or Non ischemic driven revascularization)
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Any coronary revascularization (ischemic driven, non ischemic driven)
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
ARC-2 defines Stent Thrombosis: including confirmed and possible stent thrombosis within acute, subacute, and advanced time ranges
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Stroke (Ischemic\\hemorrhagic)
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Hospitalization for heart failure
Time frame: At 1 months after the index procedure
Contrast-induced acute kidney injury
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Major bleeding (BARC 3-5)
Contact information is provided by the study sponsor or research team.
RenJi Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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