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Effects of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy on miRNAs Expression and Absolute Microvascular Resistance by Continuous Thermodilution in ST-segment Elevation Myocardial Infarction (STEMI) Patients: PiCSO-STEMI TRIAL (PiCSO-STEMI)

Primary Purpose

Anterior Myocardial Infarction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PiCSO Impulse System
Percutaneous Coronary Intervention (PCI)
Sponsored by
Fundacio Privada Mon Clinic Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years old. Anterior STEMI (ECG with persistent elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial leads (V2, V3, V4) in men or ≥ 1.5 mm (0.15 mV) in women. Culprit lesion in proximal or mid Left Anterior Descending Artery (LAD). Pre-PCI TIMI flow 0-1. Symptoms consistent with myocardial ischemia (persistent chest pain, dyspnea, nauseas/vomiting, fatigue, palpitations or syncope) present for ≤ 12 hours. The patient is eligible for primary PCI. Informed consent received and signed for study enrollment. Exclusion Criteria: Contraindication to coronary angiogram or PCI. Implants or foreign bodies in the coronary sinus. Known allergies to polyurethanes, Polyethylene Terephthalate (PET) or stainless steel. Known pregnancy or breastfeeding. Known coagulopathy. Known severe kidney disease (eGFR <=30 mL/min/1.73) and/or hemodialysis. Known large pericardial effusion or cardiac tamponade. Central hemodynamically relevant left-right shunt. Previous MI or Coronary Artery Bypass Graft (CABG). Previous history of stroke, transient ischemic attack (TIA) or reversible ischemic neurological deficit within last 6 months. Cardiopulmonary resuscitated (CPR) cardiac arrest ≥ 5 minutes whom baseline neurologic status is not present. Unconscious at presentation. Need for circulatory support. Need for invasive mechanical ventilation. Need for temporal intravenous pacemaker. Patient not suitable for femoral access. Known contraindication for adenosine administration (severe asthma, complicated Atrioventricular (AV) block, critical aortic stenosis, severe cardiac arrhythmias, severe valve diseases). Known epicardial stenosis greater than 50% distal to the culprit LAD lesion. Active participation in another drug or device investigational trial. Medical, social or psychological condition that limits the ability of patient to participate in the study. Patients with definite or probable coronavirus disease 19 diagnosis within 2 weeks prior to STEMI.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PICSO+PCI

    Standard PCI

    Arm Description

    Outcomes

    Primary Outcome Measures

    Superiority of PiCSO in reducing microvascular dysfunction
    To determine the superiority of PiCSO in reducing the microvascular dysfunction (defined as microvascular resistance >500 WU) as compared to standard of care

    Secondary Outcome Measures

    Full Information

    First Posted
    November 30, 2022
    Last Updated
    February 21, 2023
    Sponsor
    Fundacio Privada Mon Clinic Barcelona
    Collaborators
    Miracor Medical SA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05644925
    Brief Title
    Effects of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy on miRNAs Expression and Absolute Microvascular Resistance by Continuous Thermodilution in ST-segment Elevation Myocardial Infarction (STEMI) Patients: PiCSO-STEMI TRIAL
    Acronym
    PiCSO-STEMI
    Official Title
    Effects of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy on miRNAs Expression and Absolute Microvascular Resistance by Continuous Thermodilution in ST-segment Elevation Myocardial Infarction (STEMI) Patients: PiCSO-STEMI TRIAL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2024 (Anticipated)
    Primary Completion Date
    February 2025 (Anticipated)
    Study Completion Date
    February 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundacio Privada Mon Clinic Barcelona
    Collaborators
    Miracor Medical SA

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In this study we pretend to determine the molecular (miRNAs expression, angiogenic and inflammatory biomarkers) and microcirculatory (assessed by the innovative continuous intracoronary thermodilution technique) effects of PiCSO compared to a standard PCI control group in patients with high-risk anterior STEMI. Then, we aim to assess the efficacy of these molecular biomarkers as prognostic tools. Also, we will evaluate the impact of PiCSO on the coronary microcirculation beyond the acute phase in the follow-up six months after STEMI. Finally, we will assess PiCSO influence on Heart Failure (HF) clinical variables and patients' quality of life including a cost-effectiveness assessment in the mid-term follow-up one year after the STEMI event.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anterior Myocardial Infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will be randomized (1:1) to PiCSO group or standard PCI control group. Once randomized, PiCSO group patients will receive PiCSO therapy inside the catheterization laboratory.
    Masking
    Outcomes Assessor
    Masking Description
    The subjects as well as the investigator performing the procedure will not be blind to the study treatment. An independent experienced cardiologist, who will be blinded to all clinical data; will analyze anonymized Cardiac Magnetic Resonance (CMR) images for unbiased endpoints assessment.
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PICSO+PCI
    Arm Type
    Experimental
    Arm Title
    Standard PCI
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    PiCSO Impulse System
    Intervention Description
    The PiCSO Impulse System is intended to reduce infarct size by intermittently occluding the coronary sinus outflow in patients undergoing a percutaneous coronary interventional procedure for myocardial infarction and presenting with Thrombolysis in myocardial infarction (TIMI) flow of 0 or 1.
    Intervention Type
    Procedure
    Intervention Name(s)
    Percutaneous Coronary Intervention (PCI)
    Intervention Description
    Minimally invasive procedures used to open clogged coronary arteries
    Primary Outcome Measure Information:
    Title
    Superiority of PiCSO in reducing microvascular dysfunction
    Description
    To determine the superiority of PiCSO in reducing the microvascular dysfunction (defined as microvascular resistance >500 WU) as compared to standard of care
    Time Frame
    After primary PCI at time 0 after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years old. Anterior STEMI (ECG with persistent elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial leads (V2, V3, V4) in men or ≥ 1.5 mm (0.15 mV) in women. Culprit lesion in proximal or mid Left Anterior Descending Artery (LAD). Pre-PCI TIMI flow 0-1. Symptoms consistent with myocardial ischemia (persistent chest pain, dyspnea, nauseas/vomiting, fatigue, palpitations or syncope) present for ≤ 12 hours. The patient is eligible for primary PCI. Informed consent received and signed for study enrollment. Exclusion Criteria: Contraindication to coronary angiogram or PCI. Implants or foreign bodies in the coronary sinus. Known allergies to polyurethanes, Polyethylene Terephthalate (PET) or stainless steel. Known pregnancy or breastfeeding. Known coagulopathy. Known severe kidney disease (eGFR <=30 mL/min/1.73) and/or hemodialysis. Known large pericardial effusion or cardiac tamponade. Central hemodynamically relevant left-right shunt. Previous MI or Coronary Artery Bypass Graft (CABG). Previous history of stroke, transient ischemic attack (TIA) or reversible ischemic neurological deficit within last 6 months. Cardiopulmonary resuscitated (CPR) cardiac arrest ≥ 5 minutes whom baseline neurologic status is not present. Unconscious at presentation. Need for circulatory support. Need for invasive mechanical ventilation. Need for temporal intravenous pacemaker. Patient not suitable for femoral access. Known contraindication for adenosine administration (severe asthma, complicated Atrioventricular (AV) block, critical aortic stenosis, severe cardiac arrhythmias, severe valve diseases). Known epicardial stenosis greater than 50% distal to the culprit LAD lesion. Active participation in another drug or device investigational trial. Medical, social or psychological condition that limits the ability of patient to participate in the study. Patients with definite or probable coronavirus disease 19 diagnosis within 2 weeks prior to STEMI.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy on miRNAs Expression and Absolute Microvascular Resistance by Continuous Thermodilution in ST-segment Elevation Myocardial Infarction (STEMI) Patients: PiCSO-STEMI TRIAL

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