Clinical trial NCT05967663: Fractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study)
Official title: Fractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Keywords: STEMI
Coronary Artery Disease
Coronary Syndrome
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: MACCE
timeFrame: At 1 year after the index procedure
Secondary outcomes:
measure: MACCE
timeFrame: At 1 months, 6 months, 2 and 3 years after the index procedure
measure: All-cause mortality
timeFrame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
measure: Cardiovascular death
timeFrame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
measure: Myocardial Infarction
timeFrame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
measure: TVR: Target vessel revascularization
timeFrame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
measure: Any coronary revascularization
timeFrame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
measure: Stent Thrombosis
timeFrame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
measure: Stroke (Ischemic\hemorrhagic)
timeFrame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
measure: Hospitalization for heart failure
timeFrame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
measure: Contrast-induced acute kidney injury
timeFrame: At 1 months after the index procedure
measure: Major bleeding
timeFrame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Jun Pu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: