Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion

NCT03473015 | Completed Results

• 1 other identifier: OxfordRadcliffeH
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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 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.

Conditions

ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Index of Microcirculatory Resistance

  Assessment of coronary microvascular status using IMR IMR is calculated as the product of distal coronary pressure and transit time of bolus of saline during hyperaemic condition. It is a continuous variable that can range from to infinite value. Despite technically it represents a product of pressure in mmHg and time (seconds), by convention it is expressed in Units. A normal IMR value is accepted to be \< 25 U, however in STEMI patients (as in the cohort reported in the study) an IMR \> 40 U is associated to worse clinical outcome

  48 hours post primary percutaneous coronary intervention

Secondary Outcomes (2)

• Infarct Size

  24-48 hours post primary percutaneous coronary intervention

• Infarct Size 6 Months

  6 months post primary percutaneous coronary intervention

Study Arms (2)

PICSO arm

EXPERIMENTAL

STEMI patients with elevated pre-stenting index of microcirculatory resistance (IMR) greater than 40 units treated with pressure-controlled intermittent coronary sinus occlusion (PICSO)

Device: PICSO

Control

NO INTERVENTION

Matched historical cohort of STEMI patients with elevated IMR greater than 40, not treated with PICSO

Interventions

PICSO DEVICE

The PICSO Impulse catheter is a 8F double lumen catheter with a 15.5x20mm long balloon at the distal end. The balloon inflates and deflates cyclically once deployed in the coronary sinus, leading to intermitted coronary sinus pressure increase. The catheter is connected to the console through two pneumatic tubes in which helium is shuttled to and from the balloon. In addition, the coronary sinus pressure is monitored through the center lumen of the catheter.

PICSO arm

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, aged 30 to 90 years,
• Clinical presentation with STEMI
• Referred for coronary angiography with view to proceed to PCI with stenting.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Heart Centre - John Radcliffe Hospital - Oxford University Hospitals - NHS Foundation Trust

Oxford, OX37BA, United Kingdom

Location

Related Publications (11)

• Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

  PMID: 25173339 BACKGROUND

• De Maria GL, Patel N, Kassimis G, Banning AP. Spontaneous and procedural plaque embolisation in native coronary arteries: pathophysiology, diagnosis, and prevention. Scientifica (Cairo). 2013;2013:364247. doi: 10.1155/2013/364247. Epub 2013 Dec 19.

  PMID: 24455430 BACKGROUND

• Fearon WF, Low AF, Yong AS, McGeoch R, Berry C, Shah MG, Ho MY, Kim HS, Loh JP, Oldroyd KG. Prognostic value of the Index of Microcirculatory Resistance measured after primary percutaneous coronary intervention. Circulation. 2013 Jun 18;127(24):2436-41. doi: 10.1161/CIRCULATIONAHA.112.000298. Epub 2013 May 16.

  PMID: 23681066 BACKGROUND

• De Maria GL, Cuculi F, Patel N, Dawkins S, Fahrni G, Kassimis G, Choudhury RP, Forfar JC, Prendergast BD, Channon KM, Kharbanda RK, Banning AP. How does coronary stent implantation impact on the status of the microcirculation during primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction? Eur Heart J. 2015 Dec 1;36(45):3165-77. doi: 10.1093/eurheartj/ehv353. Epub 2015 Aug 7.

  PMID: 26254178 BACKGROUND

• De Maria GL, Kassimis G, Raina T, Banning AP. Reconsidering the back door approach by targeting the coronary sinus in ischaemic heart disease. Heart. 2016 Aug 15;102(16):1263-9. doi: 10.1136/heartjnl-2016-309642. Epub 2016 Jun 10.

  PMID: 27288281 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

• Khattab AA, Stieger S, Kamat PJ, Vandenberghe S, Bongoni A, Stone GW, Seiler C, Meier B, Hess OM, Rieben R. Effect of pressure-controlled intermittent coronary sinus occlusion (PICSO) on myocardial ischaemia and reperfusion in a closed-chest porcine model. EuroIntervention. 2013 Jul;9(3):398-406. doi: 10.4244/EIJV9I3A63.

  PMID: 23872654 BACKGROUND

• Syeda B, Schukro C, Heinze G, Modaressi K, Glogar D, Maurer G, Mohl W. The salvage potential of coronary sinus interventions: meta-analysis and pathophysiologic consequences. J Thorac Cardiovasc Surg. 2004 Jun;127(6):1703-12. doi: 10.1016/j.jtcvs.2004.01.036.

  PMID: 15173727 BACKGROUND

• Mohl W, Glogar DH, Mayr H, Losert U, Sochor H, Pachinger O, Kaindl F, Wolner E. Reduction of infarct size induced by pressure-controlled intermittent coronary sinus occlusion. Am J Cardiol. 1984 Mar 15;53(7):923-8. doi: 10.1016/0002-9149(84)90526-5.

  PMID: 6702648 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

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

OxAMI-PICSO was a non-randomised study. Another limitation is the number of patients without cardiac MRI (cMRI). This is a common finding in an emergency all-comers design but, while cMRI within 24-48 hours was performed in only 60% of the study population, most of these patients completed follow-up with cMRI at six months (85.7%). Thirdly, the ATI score was not used to select high-risk STEMI patients, since it was not yet validated at the time of study design.

Results Point of Contact

• Title: Professor Adrian Banning
• Organization: Oxford Heart Centre, Oxford University Hospitals, Oxford, United Kingdom

adrian.banning@ouh.nhs.uk

1865 228934

Study Officials

• Adrian Banning, MD, MBBS

  Adrian.Banning@ouh.nhs.uk

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist, Professor of Interventional Cardiology

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 21, 2018
• Study Start: July 1, 2015
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: November 14, 2023
• Results First Posted: November 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)