Fractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PCI-immediate complete revascularisation, PCI-staged complete revascularisation.
- Who it may be relevant to
- Registry conditions: ST Elevation Myocardial Infarction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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 myocardial infarction patients with multivessel coronary disease.
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.
Interventions
- Device 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. - Device 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.
Primary outcome measures
- MACCE [Time frame: At 1 year after the index procedure]
Secondary outcome measures (11)
- MACCE [Time frame: At 1 months, 6 months, 2 and 3 years after the index procedure]
- All-cause mortality [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 [Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure]
- TVR: Target vessel revascularization [Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure]
- Any coronary revascularization [Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure]
- Stent Thrombosis [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, 6 months, 1, 2 and 3 years after the index procedure]
- Contrast-induced acute kidney injury [Time frame: At 1 months after the index procedure]
- Major bleeding [Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT05967663 · Future Study