PiCSO in ACS Study
Pressure Controlled Intermittent Coronary Sinus Occlusion (PiCSO) as an Adjunct to PCI in Acute Coronary Syndrome
1 other identifier
interventional
99
1 country
4
Brief Summary
The purpose of this research study is to find out whether PICSO (Pressure Controlled Coronary Sinus Occlusion), given concomitant to (NSTEMI) or following (STEMI) primary PCI and stenting, can improve final infarct size and myocardial function. ACS patients, NSTEMI and STEMI, with a culprit lesion in the LAD will be treated according to standard treatment, PCI followed by stent placement, with or without PICSO therapy. In NSTEMI patients, PICSO therapy will be given during PCI and stenting for a minimum of 30 minutes or the duration of the PCI and stent procedure. In STEMI patients PICSO therapy will be given after successful primary percutaneous coronary intervention of a left anterior descending coronary artery culprit lesion. PICSO therapy is initiated prior to stent deployment and continued during stenting. The functional efficacy measures, related to the PICSO duration and coronary sinus pressures, will be stored on the PICSO Impulse console and analysed offline. The clinical efficacy measures, cardiac enzyme release during 24 hour following PCI, cardiac function, infarct size and level of microvascular obstruction will be assessed by cMRI. Patients will be followed for a maximum of 4 months after the primary PCI procedure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2015
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2014
CompletedFirst Posted
Study publicly available on registry
July 22, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedMarch 18, 2019
March 1, 2019
2.8 years
July 16, 2014
March 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Infarct Size assessed by cardiac MRI
Efficacy of PICSO treatment as assessed by means of infarct size reduction assessment, 4-months vs. 1 week post-primary PCI in comparison with a matched non-PICSO parallel control group
baseline and 4 months
Secondary Outcomes (4)
Enzymatic Infarct Size
12 hours post PCI
Level of Microvascular Obstruction assessed by cardia MRI
2-5 days post PCI
Absolute Infarct size assessment by cardiac MRI
baseline and 4 months
MACE
baseline to 4 months
Study Arms (2)
PICSO
ACTIVE COMPARATORParticipants enrolled in the PICSO treatment Group will be treated with PICSO concomitant to pPCI in patients with anterior non ST-segment Elevation Myocardial Infarction or following pPCI in ST-segment Elevation Myocardial Infarction
Parallel control
NO INTERVENTIONParticipants enrolled in will receive treatment based on the standard guidelines for treatment of a myocardial infarction.
Interventions
Pressure controlled Intermittent Coronary Pressure Occlusion
Eligibility Criteria
You may qualify if:
- Patients with first time symptoms of acute coronary syndrome (NSTEMI and STEMI)
- Culprit lesion in the LAD.
- Age range 25 - 75 years
You may not qualify if:
- Complicated PCI of an LAD culprit lesion (defined as angioplasty followed by stent placement or direct stenting with the occurrence of an adverse event(s) that would preclude further interventional procedures during the index procedure, such as major bleeding, perforation, hypotension, pulmonary edema or instability that in the judgment of the investigator precludes use of the PICSO Impulse System).
- Previous coronary artery bypass graft surgery
- History of stroke, TIA or reversible ischemic neurological disease within last 6 months
- Hospitalization with a primary diagnosis of acute myocardial infarction (AMI) previously or has evidence of previous Q-wave infarct
- Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
- Active or treated malignancies in the last 12 months
- Pregnant Women
- Non-cardiac comorbidities and life expectancy \< 1 year
- Use of warfarin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
Northern General Hospital
Sheffield, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Azfar Zaman, Prof. Dr.
Freeman Hospital, Newcastle
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2014
First Posted
July 22, 2014
Study Start
January 1, 2015
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
March 18, 2019
Record last verified: 2019-03