CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 105 enrolled
Drug / intervention
PICSOdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03473015
NCT03473015N/ACompleted

Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion

Oxford University Hospitals NHS Trust·interventional·Posted Mar 21, 2018·Updated Nov 14, 2023

In Brief

A clinical study evaluating PICSO for ST Elevation Myocardial Infarction. Completed, enrolled 105 participants across 1 site.

Detailed Summary

The OxAMI-PICSO is a study about the use of pressure controlled intermittent coronary sinus occlusion (PICSO) to improve the treatment of patients presenting with heart attack. PICSO is a device consisting of a balloon which is deployed in the coronary sinus. When inflated the balloon can improve the blood flow to the region of heart affected by the heart attack. The study aims to analyse the potential benefit of PICSO in improving blood flow to heart muscle in a selected group of patients admitted with a large heart attack involving the anterior wall of the heart. The comparator group will be a well-matched group of participants of the ongoing OxAMI study. In order to select patients with a large heart attack, we will measure the index of microcirculatory resistance (IMR), before completion of the heart attack treatment procedure. The IMR value provides measurement of the blood flow at the level of the tiny vessels branching from the large coronary arteries. Our preliminary data from the OxAMI study have shown that an IMR \> 40 suggests that the patient is having a large myocardial infarction (heart attack). Only patients with starting IMR \> 40 will be considered eligible for the PICSO treatment. The benefit of PICSO will be assessed by measuring 1) indexes of coronary blood flow, 2) the extension of the infarcted area and 3) the levels of different molecules released in the blood.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
CollaboratorsMiracor Medical SA

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 21, 2018
Enrollment StartJul 1, 2015
Primary CompletionOct 31, 2020
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 8.3 years ago

Interventions

PICSOdevice

The PICSO Impulse catheter is a 8F double lumen catheter with a 15.5x20mm long balloon at the distal end. The balloon inflates and deflates cyclically once deployed in the coronary sinus, leading to intermitted coronary sinus pressure increase. The catheter is connected to the console through two pneumatic tubes in which helium is shuttled to and from the balloon. In addition, the coronary sinus pressure is monitored through the center lumen of the catheter.