Fractional Flow Reserve Guided Immediate Versus Staged Co... | NCT05967663

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

NCT05967663

Sponsor

RenJi Hospital

Status

Recruiting

Last Update Posted

Dec 4, 2023Actual

Enrollment

840Estimated

Phase

Not Applicable

Conditions

ST Elevation Myocardial Infarction

Interventions

PCI-immediate complete revascularisation
PCI-staged complete revascularisation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2023Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Jul 22, 2023

First Submission Date that Met QC Criteria

Jul 22, 2023

First Posted Date

Aug 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2023

Last Update Posted Date

Dec 4, 2023Actual

Description Module

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:

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

Exclusion Criteria:

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:
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

840Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	Immediate complete revascularisation	Device: PCI-immediate complete revascularisation
Control group	Active Comparator	Staged complete revascularisation	Device: PCI-staged complete revascularisation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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 months, 6 months, 2 and 3 years after the index procedure
All-cause mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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:
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000072657	ST Elevation Myocardial Infarction
D003324	Coronary Artery Disease
D000789	Angina, Unstable

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis
D003327	Coronary Disease
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D000787	Angina Pectoris
D002637	Chest Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms