Fractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study)

Shanghai Jiao Tong University

Status: Enrolling

Conditions: ST Elevation Myocardial Infarction

Treatments: Device: PCI-immediate complete revascularisation; Device: PCI-staged complete revascularisation

Study type: Interventional

Funder types: Other

Identifiers

NCT05967663

Future Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 840 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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840 participants in 2 patient groups

Intervention group

Experimental group

Description:

Immediate complete revascularisation

Treatment:

Device: PCI-immediate complete revascularisation

Control group

Active Comparator group

Description:

Staged complete revascularisation

Treatment:

Device: PCI-staged complete revascularisation