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NCT05967663Recruiting

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

Source: ClinicalTrials.gov · Last updated 4 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
840 (estimated)
First submitted
22 Jul 2023
Start date
11 Nov 2023
Primary completion date
31 Dec 2026
Lead sponsor
RenJi Hospital
NCT number
NCT05967663

What you commit to

  • Study type: Interventional
  • Planned participants: 840
  • From 11 Nov 2023 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received thrombolytic therapy
  • PCI in the previous 30 days or Previous CABG

Other illness

  • Cardiac shock or SBP\<90mmHg;
  • History of old myocardial infarction;
  • 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.

Lab values

  • Patients combined with other serious diseases such as severe renal dysfunction (creatinine clearance value\<30ml/min;), liver dysfunction and thrombocytopenia

Other

  • Left main artery lesion, non infarct related vessels are CTO lesions;
  • Patients who cannot give informed consent or have a life expectancy of less than 1 year

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.