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

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.

Study Overview

• Status: Recruiting
• Conditions: ST Elevation Myocardial Infarction
• Intervention / Treatment: Device: PCI-immediate complete revascularisation; Device: PCI-staged complete revascularisation

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 Type: Interventional
• Enrollment (Estimated): 840
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Pu, MD, PhD; Phone Number: 86-21-68383477; Email: pujun310@hotmail.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Contact: Jun Pu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Immediate complete revascularisation	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.
Active Comparator: Control group; Staged complete revascularisation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE	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.	At 1 year after the index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality (cardiovascular death, non- cardiovascular death, undetermined cause of death)	At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Cardiovascular death	Cardiovascular death	At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Myocardial Infarction	Myocardial Infarction (Q-wave and non Q-wave MI)	At 1 months, 6 months, 1, 2 and 3 years after the index procedure
TVR: Target vessel revascularization	TVR: Target vessel revascularization(Ischemia driven revascularization, or Non ischemic driven revascularization)	At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Any coronary revascularization	Any coronary revascularization (ischemic driven, non ischemic driven)	At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Stent Thrombosis	ARC-2 defines Stent Thrombosis: including confirmed and possible stent thrombosis within acute, subacute, and advanced time ranges	At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Contrast-induced acute kidney injury	Contrast-induced acute kidney injury	At 1 months after the index procedure
Major bleeding	Major bleeding (BARC 3-5)	At 1 months, 6 months, 1, 2 and 3 years after the index procedure
MACCE	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.	At 1 months, 6 months, 2 and 3 years after the index procedure
Stroke (Ischemic\hemorrhagic)	Stroke (Ischemic\hemorrhagic)	At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Hospitalization for heart failure	Hospitalization for heart failure	At 1 months, 6 months, 1, 2 and 3 years after the index procedure

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Jun Pu, MD, PhD, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 22, 2023
• First Submitted That Met QC Criteria: July 22, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; STEMI; Coronary Syndrome
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: Future Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No