Fractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study)
NCT ID: NCT05967663
Last Updated: 2023-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
840 participants
INTERVENTIONAL
2023-11-11
2028-12-31
Brief Summary
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Detailed Description
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Inclusion Criteria:
1. Age ≥ 18 years
2. Patients presenting STEMI and multivessel coronary disease successful primary PCI of the culprit lesion (including those who still have ischemic symptoms within 48 hours)
3. 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
4. Sign an informed consent form before participating in the study
Exclusion Criteria:
1. Received thrombolytic therapy
2. Cardiac shock or SBP\<90mmHg;
3. History of old myocardial infarction;
4. Left main artery lesion, non infarct related vessels are CTO lesions;
5. PCI in the previous 30 days or Previous CABG
6. Patients who cannot give informed consent or have a life expectancy of less than 1 year
7. Patients combined with other serious diseases such as severe renal dysfunction (creatinine clearance value\<30ml/min;), liver dysfunction and thrombocytopenia
8. Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension;
9. Not suitable for clinical research:
1. . Currently participating in another study that may affect the primary endpoint
2. . Pregnant and lactating women;
3. . Known allergy to drugs that may be used in the study;
4. . 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group
Immediate complete revascularisation
PCI-immediate complete revascularisation
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.
Control group
Staged complete revascularisation
PCI-staged complete revascularisation
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.
Interventions
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PCI-immediate complete revascularisation
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.
PCI-staged complete revascularisation
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.
Eligibility Criteria
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Inclusion Criteria
2. Patients presenting STEMI and multivessel coronary disease successful primary PCI of the culprit lesion (including those who still have ischemic symptoms within 48 hours)
3. 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
4. Sign an informed consent form before participating in the study
Exclusion Criteria
2. Cardiac shock or SBP\<90mmHg;
3. History of old myocardial infarction;
4. Left main artery lesion, non infarct related vessels are CTO lesions;
5. PCI in the previous 30 days or Previous CABG
6. Patients who cannot give informed consent or have a life expectancy of less than 1 year
7. Patients combined with other serious diseases such as severe renal dysfunction (creatinine clearance value\<30ml/min;), liver dysfunction and thrombocytopenia
8. Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension;
9. Not suitable for clinical research:
1. Currently participating in another study that may affect the primary endpoint
2. Pregnant and lactating women;
3. Known allergy to drugs that may be used in the study;
4. 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.
18 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Principal Investigators
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Jun Pu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Locations
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Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Jun Pu
Role: primary
Other Identifiers
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Future Study
Identifier Type: -
Identifier Source: org_study_id