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
- Diseases
- Coronary artery disease
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.