Cardiovascular Magnetic Resonance Guided Open Artery Trial for Revascularization of Late Presenting ST Elevation Myocardial Infarction
NCT ID: NCT05374265
Last Updated: 2022-05-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
NA
Study Classification
INTERVENTIONAL
Study Start Date
2022-06-01
Study Completion Date
2023-06-01
Brief Summary
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Patients with STEMI are usually treated with primary PCI in contemporary practice. However, primary PCI is currently deemed unbeneficial or potentially harmful in patients presenting late after a STEMI. There is limited data to suggest that patients who may have viable myocardium despite presenting late with a STEMI may derive benefit from PCI, which may be denied in current practice. CMR imaging is the reference modality for assessment of left ventricular function and myocardial viability. This feasibility study will randomise late presenting STEMI patients with CMR documented viability to PCI plus optimal medical therapy (OMT) versus OMT alone. The investigator hypothesises that PCI in this cohort will improve left ventricular remodelling and function. Favourable results will lead to an adequately powered multi-centre trial with the potential to improve the management of late resenting STEMI patients and impact on clinical practice guidelines.
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Detailed Description
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Stable patients with late presenting STEMI will be prospectively recruited into this study from 5 large primary PCI centres in the UK. Ethical approval from a Research Ethics Committee and written informed consent from all participants will be obtained.
Recruited patients will receive baseline CMR to detect viability within 7 days of index admission or coronary angiogram. Patients with non-viable myocardium will be treated with standard clinical care and form part of the registry arm. Patients with viable myocardium will be randomised to revascularization with OMT vs OMT alone. PCI will be performed according to standard techniques using newer generation drug eluting stents. All patients will recieve dual anti-platelet treatment for 12 months, or as per local practice guidelines. other treatments will be given according to evidence based guidelines. Revascularization wth CABG can also be considered, based on MDT decision.
The feasibility study will randomise 60 patients (30 in PCI and 30 in OMT group). OAT-NUC trial showed that 70% late presenting STEMI may have viability. therefor, recruiting 90 patients for baseline CMR may provide 60 patients to randomise. the results of this feasibility study will inform the investigator of the numbers needed for an adequately powered multi-centre clinical trial.
Recruited patients will receive baseline CMR to detect viability within 7 days of index admission or coronary angiogram. Patients with non-viable myocardium will be treated with standard clinical care and form part of the registry arm. Patients with viable myocardium will be randomised to revascularization with OMT vs OMT alone. PCI will be performed according to standard techniques using newer generation drug eluting stents. All patients will recieve dual anti-platelet treatment for 12 months, or as per local practice guidelines. other treatments will be given according to evidence based guidelines. Revascularization wth CABG can also be considered, based on MDT decision.
The feasibility study will randomise 60 patients (30 in PCI and 30 in OMT group). OAT-NUC trial showed that 70% late presenting STEMI may have viability. therefor, recruiting 90 patients for baseline CMR may provide 60 patients to randomise. the results of this feasibility study will inform the investigator of the numbers needed for an adequately powered multi-centre clinical trial.
Conditions
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STEMI
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Registry
Patients with non-viable myocardium will be treated with standard clinical care.
Group Type
NO_INTERVENTION
No interventions assigned to this group
OMT with revascularization
Patients with viable myocadium will be randomised to OMT with revascularization. PCI will be performed according to standard techniques using newer generation drug eluting stents. All patients will receive dual anti-platelet treatment for 12 months, or as per local practice guidelines.
Group Type
OTHER
Cardiovascular Magnetic Resonance Scan
Intervention Type
OTHER
Patients will receive a baseline CMR scan to detect viability within 7 days of index admission
OMT alone
Patients with viable myocardium will be radomised to OMT alone. PCI will be performed according to standard techniques using newer generation drug eluting stents. All patients will receive dual anti-platelet treatment for 12 months, or as per local practice guidelines.
Group Type
OTHER
Cardiovascular Magnetic Resonance Scan
Intervention Type
OTHER
Patients will receive a baseline CMR scan to detect viability within 7 days of index admission
Interventions
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Cardiovascular Magnetic Resonance Scan
Patients will receive a baseline CMR scan to detect viability within 7 days of index admission
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* STEMI patients presenting \>12 hours, and within 28 days, after symptom onsent.
* Stable patients with no on-going features of ischaemia (chest pain, dynamic ECG changes)
* Stable patients with no on-going features of ischaemia (chest pain, dynamic ECG changes)
Exclusion Criteria
* Inability to give informed consent
* Standard CMR contra-indications
* Haemodynamic instability (requiring on-going intravenous therapy or respiratory support)
* Previous coronary artery bypass grafting and cardiomyopathy
* Estimated glomerular filtration rate \<30ml/min/1.73m2
* End-stage malignancy or expected life expectancy of less than 12 months.
* Standard CMR contra-indications
* Haemodynamic instability (requiring on-going intravenous therapy or respiratory support)
* Previous coronary artery bypass grafting and cardiomyopathy
* Estimated glomerular filtration rate \<30ml/min/1.73m2
* End-stage malignancy or expected life expectancy of less than 12 months.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Sheffield Teaching Hospitals NHS FT
Sheffield, England, United Kingdom
Site Status
Countries
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United Kingdom
References
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Other Identifiers
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STH20171
Identifier Type: -
Identifier Source: org_study_id
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