N/A
N=105
Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion
ST Elevation Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT03473015 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Index of Microcirculatory Resistance — 24.8; 45.0 units
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PICSO (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Oxford University Hospitals NHS Trust
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Index of Microcirculatory Resistance |
24.8; 45.0 | — |
| SECONDARY Infarct Size |
23.0; 41.0; 39.0 | — |
| SECONDARY Infarct Size 6 Months |
19.0; 33.0; 26.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or Female, aged 30 to 90 years,
- Clinical presentation with STEMI
- Referred for coronary angiography with view to proceed to PCI with stenting.
Exclusion Criteria
- Patients in whom safety or clinical concerns preclude participation.
- Known anaemia (Hb <9).
- Pregnant or breast feeding females.
- Revascularization by mean of balloon angioplasty without stenting
- History of stroke, TIA or reversible ischemic neurological disease within last 6 months
- Known severe renal failure (eGFR < 30 ml/min/1.73m2) or history of dialysis or renal transplant
- Previous coronary bypass artery grafting
- Known severe valvular abnormalities
- Previous STEMI presentation
- Presentation with cardiogenic shock
- Severe bradycardia (Heart rate < 50 beats per minutes)
- STEMI due to stent thrombosis
- Unconscious on presentation
- Non-cardiac comorbidities and life expectancy < 1 year
- Use of warfarin
- Presence of pacemaker or other electrodes in the coronary sinus
- Contraindications to adenosine
- Additional exclusion criteria for participants undergoing CMR
- claustrophobia which limits / prevents participants from remaining in CMR scanner.
- patients who cannot lie flat on the scan table.
- patients with metallic implants, pacemakers, implantable defibrillators etc, unless known to be CMR compatible.
- patients with known allergy to medium of contrast (gadolinium)
Data sourced from ClinicalTrials.gov (NCT03473015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.