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

NCT05374265 | Withdrawn

• 1 other identifier: STH20171
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI

Outcome Measures

Primary Outcomes (1)

• Change in LV end-systolic volume

  Change in LV end-systolic volume from baseline to 3-month CMR.

  from baseline to 3-months

Study Arms (3)

Registry

NO INTERVENTION

Patients with non-viable myocardium will be treated with standard clinical care.

OMT with revascularization

OTHER

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.

Other: Cardiovascular Magnetic Resonance Scan

OMT alone

OTHER

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.

Other: Cardiovascular Magnetic Resonance Scan

Interventions

Cardiovascular Magnetic Resonance Scan OTHER

Patients will receive a baseline CMR scan to detect viability within 7 days of index admission

OMT alone; OMT with revascularization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS FT

Sheffield, England, S10 2JF, United Kingdom

Location

Related Publications (28)

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MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)