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

NCT05967663 | Recruiting DMC

• 1 other identifier: Future Study
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

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.

Conditions

ST Elevation Myocardial Infarction

Keywords

STEMI; Coronary Artery Disease; Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• MACCE

  At 1 months, 6 months, 2 and 3 years after the index procedure

• All-cause mortality

  At 1 months, 6 months, 1, 2 and 3 years after the index procedure

• Cardiovascular death

  At 1 months, 6 months, 1, 2 and 3 years after the index procedure

• Myocardial Infarction

  At 1 months, 6 months, 1, 2 and 3 years after the index procedure

• TVR: Target vessel revascularization

  At 1 months, 6 months, 1, 2 and 3 years after the index procedure

Study Arms (2)

Intervention group

EXPERIMENTAL

Immediate complete revascularisation

Device: PCI-immediate complete revascularisation

Control group

ACTIVE COMPARATOR

Staged complete revascularisation

Device: PCI-staged complete revascularisation

Interventions

PCI-immediate complete revascularisation DEVICE

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.

Intervention group

PCI-staged complete revascularisation DEVICE

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Coronary Artery Disease; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jun Pu, MD, PhD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Pu, MD, PhD

CONTACT

86-21-68383477; pujun310@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2023
• First Posted: August 1, 2023
• Study Start: November 11, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 4, 2023

Record last verified: 2023-12

Locations

CN (1)