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Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion (OxAMI-PICSO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03473015
Recruitment Status : Completed
First Posted : March 21, 2018
Last Update Posted : January 13, 2021
Sponsor:
Collaborator:
Miracor Medical SA
Information provided by (Responsible Party):
Adrian Banning, Oxford University Hospitals NHS Trust

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.


Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Device: PICSO Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : October 31, 2020
Actual Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: PICSO arm
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
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.

No Intervention: Control
Matched historical cohort of STEMI patients with elevated IMR greater than 40, not treated with PICSO



Primary Outcome Measures :
  1. Index of microcirculatory resistance [ Time Frame: 48 hours post primary percutaneous coronary intervention ]
    Assessment of coronary microvascular status using IMR


Secondary Outcome Measures :
  1. Infarct Size [ Time Frame: 24-48 hours post primary percutaneous coronary intervention ]
    Infarct size measured by Cardiac magnetic resonance

  2. Infarct Size 6 months [ Time Frame: 6 months post primary percutaneous coronary intervention ]
    Infarct size measured by Cardiac magnetic resonance



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473015


Locations
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United Kingdom
Heart Centre - John Radcliffe Hospital - Oxford University Hospitals - NHS Foundation Trust
Oxford, United Kingdom, OX37BA
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Miracor Medical SA
Investigators
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Study Chair: Adrian Banning, MD, MBBS Adrian.Banning@ouh.nhs.uk
Publications:

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Responsible Party: Adrian Banning, Consultant Cardiologist, Professor of Interventional Cardiology, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03473015    
Other Study ID Numbers: OxfordRadcliffeH
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases