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

NCT03473015 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2023-11-14

Study results available
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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.

Conditions

  • ST Elevation Myocardial Infarction

Interventions

DEVICE

PICSO

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.

Sponsors & Collaborators

  • Miracor Medical SA

    collaborator INDUSTRY

  • Oxford University Hospitals NHS Trust

    lead OTHER

Principal Investigators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2020-10-31
Completion
2020-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03473015 on ClinicalTrials.gov