Cardiovascular Magnetic Resonance Guided Open Artery Trial for Revascularization of Late Presenting ST Elevation Myocardial Infarction

Not Applicable

Withdrawn

• Conditions: STEMI
• Interventions: Other: Cardiovascular Magnetic Resonance Scan

• Registration Number: NCT05374265
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-13
• Last Update Submitted: 2022-05-13
• Study First Posted: 2022-05-16
• Last Update Posted: 2022-05-16
• Study Start: 2022-06-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMT with revascularization	Cardiovascular Magnetic Resonance Scan	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.
OMT alone	Cardiovascular Magnetic Resonance Scan	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.

Primary Outcome Measures

Name	Time	Method
Change in LV end-systolic volume	from baseline to 3-months	Change in LV end-systolic volume from baseline to 3-month CMR.

Trial Locations

Locations (1)

Sheffield Teaching Hospitals NHS FT; 🇬🇧 Sheffield, England, United Kingdom