Status:
RECRUITING
Fractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study)
Lead Sponsor:
RenJi Hospital
Conditions:
ST Elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
It is a prospective, multicenter, randomised controlled, open-label, blinded endpoint assessment trial, to compare the strategy of immediate complete revascularisation and staged complete revascularis...
Detailed Description
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 myocard...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Patients presenting STEMI and multivessel coronary disease successful primary PCI of the culprit lesion (including those who still have ischemic symptoms within 48 hours)
- Multivessel disease was defined at least one non-culprit coronary arteries with a diameter of 2.5 mm or more and a maximum diameter at least 50% stenosis by visual estimation, PCI can be successfully implemented
- Sign an informed consent form before participating in the study
Exclusion
- Received thrombolytic therapy
- Cardiac shock or SBP\<90mmHg;
- History of old myocardial infarction;
- Left main artery lesion, non infarct related vessels are CTO lesions;
- PCI in the previous 30 days or Previous CABG
- Patients who cannot give informed consent or have a life expectancy of less than 1 year
- Patients combined with other serious diseases such as severe renal dysfunction (creatinine clearance value\<30ml/min;), liver dysfunction and thrombocytopenia
- Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension;
- Not suitable for clinical research:
- Currently participating in another study that may affect the primary endpoint
- Pregnant and lactating women;
- Known allergy to drugs that may be used in the study;
- Unable to comply with the trial protocol or follow-up requirements; Or the researcher believes that participating in the trial may result in patients facing greater risks.
Key Trial Info
Start Date :
November 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT05967663
Start Date
November 11 2023
End Date
December 1 2028
Last Update
December 4 2023
Active Locations (1)
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1
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China