The Pressure-controlled Intermittent Coronary Sinus Occlusion on VentrIcular PERformance Study

Launched by OXFORD UNIVERSITY HOSPITALS NHS TRUST · Jul 24, 2019

Keywords

ClinConnect Summary

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 physiology parameters, namely fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) will be measured, using a pressure wire, as used for routine clinical measurements in patients undergoing PCI.
* Via a separate arterial access, a conductance catheter will be inserted retrogradely in the left ventricle for baseline measurements of cardiac pump...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.