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

ST Elevation Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05967663
• Other study ID #: Future Study
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2023
• Est. completion date: December 2028

Study information

• Verified date: December 2023
• Source: RenJi Hospital
• Contact: Jun Pu, MD, PhD
• Phone: 86-21-68383477
• Email: pujun310[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 840
• Est. completion date: December 2028
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Cardiovascular death	Cardiovascular death	At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Stroke (Ischemic\hemorrhagic)	Stroke (Ischemic\hemorrhagic)	At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Secondary	Hospitalization for heart failure	Hospitalization for heart failure	At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Secondary	Contrast-induced acute kidney injury	Contrast-induced acute kidney injury	At 1 months after the index procedure
Secondary	Major bleeding	Major bleeding (BARC 3-5)	At 1 months, 6 months, 1, 2 and 3 years after the index procedure