Microvascular Obstruction with the CoFI™ System Assessment - MOCA I
Research type
Research Study
Full title
MOCA I Study – Microvascular Obstruction with the CoFI™ System Assessment
IRAS ID
1006897
Contact name
Heerajnarain Bulluck
Contact email
Sponsor organisation
Corflow Therapeutics
Clinicaltrials.gov Identifier
Research summary
Modern primary PCI STEMI treatment is effective in restoring epicardial flow. However Microvascular Obstruction (MVO) is present in nearly 60% of cases where PPCI fails to achieve effective myocardial reperfusion. As a result, 1 in 5 anterior STEMI patients return with heart failure and mortality rates remain close to 10% at 1 year. Although these outcomes are closely related to infarct size (IS), recent research shows that MVO has greater prognostic value for adverse outcomes. The gold standard for MVO detection is cardiac MRI, which is not routinely utilized and is not routinely utilized and is not performed early in the management of STEMI. No direct measurement of MVO in the catheterization laboratory is routinely implemented in patients with anterior STEMI. The MOCA I first in human study evaluates the safety and feasibility of a novel real-time catheter-based system (CoFI system) to detect MVO immediately after PPCI, with the capability to timely deliver a therapeutic intracoronary agent (Tirofiban/Aggrastat). If successful, this study and system could enable novel diagnostic and therapeutic opportunities.
MOCA I is enrolling anterior NSTEMI and STEMI patients undergoing PPCI within 6 hours from symptom onset. After standard (p)PCI, Phase I (NSTEMI) and Phase II (STEMI) patients undergo a diagnostic CoFI procedure for detection of MVO. Phase III (STEMI) patients will additionally undergo a therapeutic (intracoronary administration of Aggrastat) procedure and a second diagnostic. All patients undergo CMRI 3-5 days after (p)PCI for detection of the myocardium affected by a deficit of perfusion despite culprit vessel recanalization. A follow up is planned at discharge, 30 days and 6 months. Up to 7 investigation sites in the UK, Switzerland and Lithuania will participate into the study. Enrollment into the study will last up to December 2023.REC name
HSC REC B
REC reference
23/NI/0086
Date of REC Opinion
22 Sep 2023
REC opinion
Further Information Favourable Opinion