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PiCSO-AMI-I

  • Research type

    Research Study

  • Full title

    Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction (PiCSO-AMI-I)

  • IRAS ID

    259683

  • Contact name

    Jozef Tanczos

  • Contact email

    clinical@miracormedical.com

  • Clinicaltrials.gov Identifier

    NCT03625869

  • Duration of Study in the UK

    4 years, 5 months, 30 days

  • Research summary

    In patients suffering from myocardial infarction (MI, heart attack), the blood flow in a part of the heart muscle is blocked or reduced and the heart receives less oxygen and nutrients. The affected part of the heart muscle will in most cases die and create a scar. This scar prevents the heart from working efficiently. This can lead to heart failure depending on the size of the heart muscle that is damaged.

    Myocardial infarctions can be divided into two types:
    - Non-ST-segment Elevated Myocardial Infarction (NSTEMI) is the less severe type with partial occlusion of the coronary arteries that evolves over the time.
    - ST-Segment Elevated Myocardial Infarction (STEMI) is the severe type, where the coronary artery is suddenly completely or mostly blocked off.

    Though survival after acute STEMI has considerably improved, STEMI is still one of the leading causes of mortality and morbidity worldwide. Pressure Controlled Intermittent Coronary Sinus Occlusion (PiCSO) was developed in order to address some of the limitations of today’s treatment for heart attacks. PiCSO aims to reduce the size of the scar after the heart attack and so better preserve the pump function of the heart.

    The purpose of this study is to evaluate the effect of the PiCSO treatment and to compare it to standard of care. The largest group in this study will consist of 144 STEMI patients who require immediate treatment. These patients will be randomly assigned to standard therapy in combination with PiCSO treatment or to standard therapy only. A smaller group of NSTEMI patients (approximately 30) requiring less urgent treatment will be assigned to standard therapy in combination with PiCSO. The study will last for 3 years and will be conducted in approximately 7 hospitals (5 UK and 2 other sites in France and Switzerland).

  • REC name

    South Central - Oxford C Research Ethics Committee

  • REC reference

    19/SC/0050

  • Date of REC Opinion

    12 Jul 2019

  • REC opinion

    Further Information Favourable Opinion