NCT03473015: OxAMI-PICSO

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

Completed NA Results posted Last updated 14 November 2023

What this trial tests

NA trial testing PICSO in ST Elevation Myocardial Infarction in 105 participants. Completed in 31 October 2020.

Timeline

1 July 2015

Primary endpoint
31 October 2020

31 October 2020

Quick facts

Lead sponsor	Oxford University Hospitals NHS Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	105
Start date	1 July 2015
Primary completion	31 October 2020
Estimated completion	31 October 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• PICSO

Conditions studied

• ST Elevation Myocardial Infarction — all drugs for ST Elevation Myocardial Infarction →

Sponsor

Oxford University Hospitals NHS Trust

Who can join

Adults 30 to 90, any sex, with ST Elevation Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Index of Microcirculatory Resistance Primary · 48 hours post primary percutaneous coronary intervention

Assessment of coronary microvascular status using IMR IMR is calculated as the product of distal coronary pressure and transit time of bolus of saline during hyperaemic condition. It is a continuous variable that can range from to infinite value. Despite technically it represents a product of pressure in mmHg and time (seconds), by convention it is expressed in Units. A normal IMR value is accepted to be \< 25 U, however in STEMI patients (as in the cohort reported in the study) an IMR \> 40 U is associated to worse clinical outcome

Group	Value	95% CI
PICSO Treatment Group	24.8	18.5 – 35.9
Control Group	45.0	32.0 – 51.3

Infarct Size Secondary · 24-48 hours post primary percutaneous coronary intervention

Infarct size measured by Cardiac magnetic resonance Infarct size is measured at cardiac magnetic resonance imaging scan and is expressed as hyperhanced core after gadolinium contrast dye injection. Infarct size is measured in gram of myocardial tissue and for standardization typically expressed and reported as percentage of whole left ventricular myocardial mass.

Group	Value	95% CI
Pre-stenting IMR ≤ 40 Units Group	23.0	19.0 – 53.9
Control Group	41.0	31.5 – 46.0
PICSO Treatment Group	39.0	27.5 – 44.0

Infarct Size 6 Months Secondary · 6 months post primary percutaneous coronary intervention

Infarct size measured by Cardiac magnetic resonance Infarct size is measured at cardiac magnetic resonance imaging scan and is expressed as hyperhanced core after gadolinium contrast dye injection. Infarct size is measured in gram of myocardial tissue and for standardization typically expressed and reported as percentage of whole left ventricular myocardial mass.

Group	Value	95% CI
Pre-stenting IMR ≤ 40 Units Group	19.0	10.7 – 28.0
Control Group	33.0	28.0 – 37.0
PICSO Treatment Group	26.0	20.2 – 30.0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.