Cardiovascular Magnetic Resonance Guided Open Artery Trial for Revascularization of Late Presenting ST Elevation Myocardial Infarction (CRM-OAT)

May 13, 2022 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Cardiovascular Magnetic Resonance Guided Open Artery Trial for Revascularization of Late Presenting ST Elevation Myocardial Infarction: The CRM-OAT Pilot Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Sheffield, England, United Kingdom, S10 2JF
        • Sheffield Teaching Hospitals NHS FT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Registry
Patients with non-viable myocardium will be treated with standard clinical care.
Other: 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.
Other: Cardiovascular Magnetic Resonance Scan
Patients will receive a baseline CMR scan to detect viability within 7 days of index admission
Other: 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.
Other: Cardiovascular Magnetic Resonance Scan
Patients will receive a baseline CMR scan to detect viability within 7 days of index admission

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in LV end-systolic volume
Time Frame: from baseline to 3-months
Change in LV end-systolic volume from baseline to 3-month CMR.
from baseline to 3-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

May 10, 2022

First Submitted That Met QC Criteria

May 13, 2022

First Posted (Actual)

May 16, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2022

Last Update Submitted That Met QC Criteria

May 13, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH20171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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