ST Elevation Myocardial InfarctionNCT05967663
Fractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study)
A study testing PCI-immediate complete revascularisation and PCI-staged complete revascularisation in people with ST Elevation Myocardial Infarction, run by RenJi Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- PCI-immediate complete revascularisation and PCI-staged complete revascularisation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Jun Pu
About this 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.
Read the 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:
- . 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.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- PCI-immediate complete revascularisation, PCI-staged complete revascularisation
- Keywords
- STEMI, Coronary Artery Disease, Coronary Syndrome
- Medical subject headings
- ST Elevation Myocardial Infarction, Coronary Artery Disease, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI-immediate complete revascularisationDevice
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 revascularisationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Immediate complete revascularisation Receives: Device: PCI-immediate complete revascularisation |
| Control group | Active comparator | Staged complete revascularisation Receives: Device: PCI-staged complete revascularisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 year after the index procedure
Secondary outcomes (11)
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.
Measured: At 1 months, 6 months, 2 and 3 years after the index procedure
All-cause mortality
All-cause mortality (cardiovascular death, non- cardiovascular death, undetermined cause of death)
Measured: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Cardiovascular death
Cardiovascular death
Measured: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Myocardial Infarction
Myocardial Infarction (Q-wave and non Q-wave MI)
Measured: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
TVR: Target vessel revascularization
TVR: Target vessel revascularization(Ischemia driven revascularization, or Non ischemic driven revascularization)
Measured: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Any coronary revascularization
Any coronary revascularization (ischemic driven, non ischemic driven)
Measured: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Stent Thrombosis
ARC-2 defines Stent Thrombosis: including confirmed and possible stent thrombosis within acute, subacute, and advanced time ranges
Measured: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Stroke (Ischemic\hemorrhagic)
Stroke (Ischemic\hemorrhagic)
Measured: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Hospitalization for heart failure
Hospitalization for heart failure
Measured: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Contrast-induced acute kidney injury
Contrast-induced acute kidney injury
Measured: At 1 months after the index procedure
Major bleeding
Major bleeding (BARC 3-5)
Measured: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start11 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Pu, MD, PhD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967663
- Sponsor's protocol ID
- Future Study
- Status last verified
- Dec 2023
- First submitted
- 22 Jul 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05967663
- Acronym / sponsor ID
- Future Study
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- STEMI, Coronary Artery Disease, Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- . 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: PCI-immediate complete revascularisationImmediate complete revascularisation |
| Control group | Active comparator | Device: PCI-staged complete revascularisationStaged complete revascularisation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCI-immediate complete revascularisationIn 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. | Device | Intervention group |
| PCI-staged complete revascularisationIn 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. | Device | Control group |
Primary outcome
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.
11 secondary outcomes
MACCE
Time frame: At 1 months, 6 months, 2 and 3 years after the index procedure
All-cause mortality
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Cardiovascular death
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Myocardial Infarction
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
TVR: Target vessel revascularization
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Any coronary revascularization
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Stent Thrombosis
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Stroke (Ischemic\hemorrhagic)
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Hospitalization for heart failure
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Contrast-induced acute kidney injury
Time frame: At 1 months after the index procedure
Major bleeding
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Pu, MD, PhD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI-immediate complete revascularisation and PCI-staged complete revascularisation in people with ST Elevation Myocardial Infarction, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Pu, MD, PhD (86-21-68383477, pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (time frame: At 1 year after the index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.