Status:
TERMINATED
The Pressure-controlled Intermittent Coronary Sinus Occlusion on VentrIcular PERformance Study
Lead Sponsor:
Oxford University Hospitals NHS Trust
Collaborating Sponsors:
Miracor Medical SA
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
The PICSO ViPER study is a prospective single centre cohort study of the use of PICSO in patients presenting acute myocardial infarction and impaired function of the left ventricle and candidate to an...
Detailed Description
In detail, the five stages of the PICSO VIPER study include: Stage 1: Baseline * Diagnostic angiography will be performed in the standard manner using appropriate catheters. * Pre-stenting coronary ...
Eligibility Criteria
Inclusion
- Admission with NSTEMI and considered for coronary angiogram for a view for PCI
- Echocardiographic evidence of at least mild left ventricular systolic impairment (Ejection Fraction \< 50%) or regional wall motion abnormalities in LAD territory
- Angiographically proven stenosis of the LAD treated with PCI
Exclusion
- Patient referred for surgical revascularization or considered for medical management of coronary disease
- Planned revascularization by mean of balloon angioplasty without stenting
- Patients in whom safety or clinical concerns preclude participation. These would include:
- Significant left main stem disease
- Cardiogenic shock and/or haemodynamic instability at the time of enrolment/screening
- Recent PCI or admission with acute coronary syndrome in the previous 3 months before screening/enrolment
- Known anaemia (Hb \< 90 g/L)
- Pregnant or breast-feeding females
- History of stroke, TIA or reversible ischaemic 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
- Previous PCI to LAD
- Known severe valvular abnormalities
- Use of warfarin
- Presence of pacemaker electrode or medical device in the coronary sinus
- History of inability or, in the opinion of the investigator, anticipated inability to tolerate pharmacologic stress testing (e.g. second- or third-degree AV block without a cardiac pacemaker, severe asthma, resting systolic blood pressure \<90mmHg, unstable coronary disease, use of medications which may interfere with the test).
- Unwilling, or unable, to give informed consent.
Key Trial Info
Start Date :
August 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2022
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04032925
Start Date
August 3 2021
End Date
December 29 2022
Last Update
August 21 2023
Active Locations (1)
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1
Oxford Heart Centre
Oxford, United Kingdom, OX39DU