Status:
COMPLETED
Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion
Lead Sponsor:
Oxford University Hospitals NHS Trust
Collaborating Sponsors:
Miracor Medical SA
Conditions:
ST Elevation Myocardial Infarction
Eligibility:
All Genders
30-90 years
Phase:
NA
Brief 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 consi...
Detailed Description
The OxAMI-PICSO study is a prospective single centre observational cohort study of the use of pressure-control intermittent coronary sinus occlusion (PICSO) in patients presenting for primary percutan...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2020
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT03473015
Start Date
July 1 2015
End Date
October 31 2020
Last Update
November 14 2023
Active Locations (1)
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1
Heart Centre - John Radcliffe Hospital - Oxford University Hospitals - NHS Foundation Trust
Oxford, United Kingdom, OX37BA