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

NCT04032925 | Terminated Phase 2

• 1 other identifier: 14338
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 angioplasty the left anterior descending (LAD) coronary artery. The percutaneous coronary intervention (PCI) procedure will be undertaken in a standard fashion, in accordance with the Oxford University Hospitals NHS Trust (OUHT) departmental guidelines for PCI, and includes the use of pressure wire measurements before and after stent deployment. PICSO treatment will be added on top of the conventional treatment. The protocol will constitute of 5 main stages (that will all be performed during index angioplasty procedure). The protocol is complete at the end of the angioplasty procedure, and the patient will exit the study at this point. The five stages of the protocol are described below (for details see "Detailed Description"):

• Baseline
• PICSO treatment during pre-dilation
• Stenting with PICSO support
• Post-stent Physiology
• PICSO treatment during post-dilation

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (8)

• End-systolic pressure volume relationship (ESPVR)

  Parameter of ventricular physiology and performance

  At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)

• End diastolic pressure volume relationship (EDPVR)

  Parameter of ventricular physiology and performance

  At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)

• Minimum dp/dt

  Parameter of ventricular physiology and performance

  At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)

• Maximum dp/dt

  Parameter of ventricular physiology and performance

  At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)

• Tau

  Parameter of ventricular physiology and performance

  At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)

• Stroke work

  Parameter of ventricular physiology and performance

  At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)

• Pressure-Volume Area (PVA)

  Parameter of ventricular physiology and performance

  At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)

• Cardiac Efficiency

  Parameter of ventricular physiology and performance

  At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)

Secondary Outcomes (3)

• Transcoronary gradient of lactates levels

  At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)

• Transcoronary oxygen content

  At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)

• Transcoronary microRNA gradient

  At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)

Other Outcomes (10)

• Measurement of IMR

  At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)

• Measurement of CFR

  At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)

• Measurement of Coronary wedge pressure during balloon occlusion.

  At completion of index percutaneous coronary intervention (on average 90 minutes post enrolment)

Study Arms (1)

PICSO therapy Group

EXPERIMENTAL

This will be the only treatment of the PICSO VIPER study. Within this group patients will be randomised to have cycles of 2 minutes of balloon-induced myocardial schema with PICSO device in "ON" vs "OFF" modality.

Device: PICSO

Interventions

PICSO DEVICE

PICSO therapy is delivered through the PICSO Impulse System, which consists of the PICSO Impulse console and PICSO impulse catheter. The PICSO therapy is delivered in each patient for a minimum of 20 minutes to a maximum of 45 minutes. The PICSO Impulse catheter is automatically activated by the PICSO Impulse console. It is inserted in the coronary sinus via femoral vein access. The PICSO Impulse Console cyclically inflates and deflates the balloon at the tip of the PICSO Impulse catheter, generating transient increase in coronary sinus pressure.

PICSO therapy Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• Miracor Medical SA: collaborator

Study Sites (1)

Oxford Heart Centre

Oxford, OX39DU, United Kingdom

Location

Related Publications (13)

• Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.

  PMID: 30165437 BACKGROUND

• Kirtane AJ, Moses JW. Revascularization in heart failure: the role of percutaneous coronary intervention. Heart Fail Clin. 2007 Apr;3(2):229-35. doi: 10.1016/j.hfc.2007.05.003.

  PMID: 17643923 BACKGROUND

• Martinez GJ, Yong AS, Fearon WF, Ng MK. The index of microcirculatory resistance in the physiologic assessment of the coronary microcirculation. Coron Artery Dis. 2015 Aug;26 Suppl 1:e15-26. doi: 10.1097/MCA.0000000000000213.

  PMID: 26247265 BACKGROUND

• Lazar HL, Rajaii A, Roberts AJ. Reversal of reperfusion injury after ischemic arrest with pressure-controlled intermittent coronary sinus occlusion. J Thorac Cardiovasc Surg. 1988 Apr;95(4):637-42.

  PMID: 3352298 BACKGROUND

• Spaan JA. Mechanical determinants of myocardial perfusion. Basic Res Cardiol. 1995 Mar-Apr;90(2):89-102. doi: 10.1007/BF00789439. No abstract available.

  PMID: 7646422 BACKGROUND

• Duncker DJ, Bache RJ. Regulation of coronary blood flow during exercise. Physiol Rev. 2008 Jul;88(3):1009-86. doi: 10.1152/physrev.00045.2006.

  PMID: 18626066 BACKGROUND

• Lazar HL. Advantages of pressure-controlled intermittent coronary sinus occlusion over left ventricle-powered coronary sinus retroperfusion. Ann Thorac Surg. 2001 Jan;71(1):402. doi: 10.1016/s0003-4975(00)02036-1. No abstract available.

  PMID: 11216805 BACKGROUND

• Martin JS, Byrne JG, Ghez OY, Sayeed-Shah U, Grachev SD, Laurence RG, Cohn LH. LV-powered coronary sinus retroperfusion reduces infarct size in acutely ischemic pigs. Ann Thorac Surg. 2000 Jan;69(1):84-9. doi: 10.1016/s0003-4975(99)00865-6.

  PMID: 10654492 BACKGROUND

• Ido A, Hasebe N, Matsuhashi H, Kikuchi K. Coronary sinus occlusion enhances coronary collateral flow and reduces subendocardial ischemia. Am J Physiol Heart Circ Physiol. 2001 Mar;280(3):H1361-7. doi: 10.1152/ajpheart.2001.280.3.H1361.

  PMID: 11179085 BACKGROUND

• Mohl W, Mina S, Milasinovic D, Kasahara H, Wei S, Maurer G. Is activation of coronary venous cells the key to cardiac regeneration? Nat Clin Pract Cardiovasc Med. 2008 Sep;5(9):528-30. doi: 10.1038/ncpcardio1298. No abstract available.

  PMID: 18679384 BACKGROUND

• Van de Hoef TP, Nolte F, Delewi R, Henriques JP, Spaan JA, Tijssen JG, Siebes M, Wykrzykowska JJ, Stone GW, Piek JJ. Intracoronary hemodynamic effects of pressure-controlled intermittent coronary sinus occlusion (PICSO): results from the First-In-Man Prepare PICSO Study. J Interv Cardiol. 2012 Dec;25(6):549-56. doi: 10.1111/j.1540-8183.2012.00768.x. Epub 2012 Sep 20.

  PMID: 22994798 BACKGROUND

• van de Hoef TP, Nijveldt R, van der Ent M, Neunteufl T, Meuwissen M, Khattab A, Berger R, Kuijt WJ, Wykrzykowska J, Tijssen JG, van Rossum AC, Stone GW, Piek JJ. Pressure-controlled intermittent coronary sinus occlusion (PICSO) in acute ST-segment elevation myocardial infarction: results of the Prepare RAMSES safety and feasibility study. EuroIntervention. 2015 May;11(1):37-44. doi: 10.4244/EIJY15M03_10.

  PMID: 25868741 BACKGROUND

• De Maria GL, Alkhalil M, Borlotti A, Wolfrum M, Gaughran L, Dall'Armellina E, Langrish JP, Lucking AJ, Choudhury RP, Kharbanda RK, Channon KM, Banning AP. Index of microcirculatory resistance-guided therapy with pressure-controlled intermittent coronary sinus occlusion improves coronary microvascular function and reduces infarct size in patients with ST-elevation myocardial infarction: the Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion study (OxAMI-PICSO study). EuroIntervention. 2018 Jun 8;14(3):e352-e359. doi: 10.4244/EIJ-D-18-00378.

  PMID: 29792403 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Giovanni Luigi De Maria, MD, PhD

  Oxford University Hospitals - NHS Foudation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: July 25, 2019
• Study Start: August 3, 2021
• Primary Completion: December 29, 2022
• Study Completion: December 29, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)