Ignite Creation Date:
2024-05-06 @ 5:38 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05374265
Status:
WITHDRAWN
Last Update Posted:
2022-05-16
First Post:
2022-05-10
Brief Title:
Cardiovascular Magnetic Resonance Guided Open Artery Trial for Revascularization of Late Presenting ST Elevation Myocardial Infarction
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
Cardiovascular Magnetic Resonance Guided Open Artery Trial for Revascularization of Late Presenting ST Elevation Myocardial Infarction The CRM-OAT Pilot Trial
Status:
WITHDRAWN
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding Unsuccessful
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRM-OAT
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None