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NCT Number: NCT05967663

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location status: Recruiting

Location contact

Jun Pu

CONTACT

About this study

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:
  • . 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. MACCE

    Time frame: 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 outcomes

  1. MACCE

    Time frame: 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.

  2. All-cause mortality

    Time frame: 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)

  3. Cardiovascular death

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

    Cardiovascular death

  4. Myocardial Infarction

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

    Myocardial Infarction (Q-wave and non Q-wave MI)

  5. TVR: Target vessel revascularization

    Time frame: 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)

  6. Any coronary revascularization

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

    Any coronary revascularization (ischemic driven, non ischemic driven)

  7. Stent Thrombosis

    Time frame: 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

  8. Stroke (Ischemic\hemorrhagic)

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

    Stroke (Ischemic\\hemorrhagic)

  9. Hospitalization for heart failure

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

    Hospitalization for heart failure

  10. Contrast-induced acute kidney injury

    Time frame: At 1 months after the index procedure

    Contrast-induced acute kidney injury

  11. Major bleeding

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

    Major bleeding (BARC 3-5)

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Pu, MD, PhD

CONTACT

[email protected]

86-21-68383477

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Aug 1, 2023
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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