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

Not Applicable

Recruiting

• Conditions: ST Elevation Myocardial Infarction
• Interventions: Device: PCI-staged complete revascularisation; Device: PCI-immediate complete revascularisation

• Registration Number: NCT05967663
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study First Submitted: 2023-07-22
• Study First Submitted QC: 2023-07-22
• Study First Posted: 2023-08-01
• Study Start: 2023-11-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-04
• Primary Completion: 2026-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 840

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	PCI-staged complete revascularisation	Staged complete revascularisation
Intervention group	PCI-immediate complete revascularisation	Immediate complete revascularisation

Primary Outcome Measures

Name	Time	Method
MACCE	At 1 year after the index procedure	The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischemia-driven revascularization, stroke or hospitalization for heart failure at 1 year after the index procedure.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	At 1 months, 6 months, 1, 2 and 3 years after the index procedure	All-cause mortality (cardiovascular death, non- cardiovascular death, undetermined cause of death)
Cardiovascular death	At 1 months, 6 months, 1, 2 and 3 years after the index procedure	Cardiovascular death
Myocardial Infarction	At 1 months, 6 months, 1, 2 and 3 years after the index procedure	Myocardial Infarction (Q-wave and non Q-wave MI)
TVR: Target vessel revascularization	At 1 months, 6 months, 1, 2 and 3 years after the index procedure	TVR: Target vessel revascularization(Ischemia driven revascularization, or Non ischemic driven revascularization)
Stroke (Ischemic\hemorrhagic)	At 1 months, 6 months, 1, 2 and 3 years after the index procedure	Stroke (Ischemic\\hemorrhagic)
Any coronary revascularization	At 1 months, 6 months, 1, 2 and 3 years after the index procedure	Any coronary revascularization (ischemic driven, non ischemic driven)
Contrast-induced acute kidney injury	At 1 months after the index procedure	Contrast-induced acute kidney injury
MACCE	At 1 months, 6 months, 2 and 3 years after the index procedure	The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischemia-driven revascularization, stroke or hospitalization for heart failure at 1 year after the index procedure.
Stent Thrombosis	At 1 months, 6 months, 1, 2 and 3 years after the index procedure	ARC-2 defines Stent Thrombosis: including confirmed and possible stent thrombosis within acute, subacute, and advanced time ranges
Hospitalization for heart failure	At 1 months, 6 months, 1, 2 and 3 years after the index procedure	Hospitalization for heart failure
Major bleeding	At 1 months, 6 months, 1, 2 and 3 years after the index procedure	Major bleeding (BARC 3-5)

Trial Locations

Locations (1)

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China