PICSO in Patients With STEMI Treated by Primary Percutaneous Coronary Intervention (pRAMSES)
Primary Purpose
ST Elevation (STEMI) Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PICSO (Pressure-controlled Intermittent Coronary Occlusion
Sponsored by
About this trial
This is an interventional treatment trial for ST Elevation (STEMI) Myocardial Infarction focused on measuring STEMI, PICSO, Coronary Sinus, Involving Left Anterior Descending Coronary Artery
Eligibility Criteria
Inclusion Criteria:
First time anterior STEMI defined by the following:
- Symptoms of myocardial ischemia > 30 minutes and < 12 hours
- ST-segment elevation > 1mm (> 0.1 mV) in two contiguous precordial leads in the anterior territory on a 12-lead ECG
- Uncomplicated PCI of a LAD culprit lesion (defined as angioplasty followed by stent placement or direct stenting without the occurrence of an adverse event(s) that would preclude further study participation, such as major bleeding, perforation, hypotension, pulmonary edema or instability that in the judgement of the investigator preclude participation in the trial)
Exclusion Criteria:
- Younger than 18 years of age
- Hospitalization with a primary diagnosis of acute myocardial infarction (AMI) previously or has evidence of previous Q-wave infarct
- Left main coronary artery culprit lesion
- Additional stenosis in the LAD for which PCI or CABG is likely to be needed in the next 6 months and which is not treated during the index procedure
- Cardiogenic shock (systolic blood pressure ≤90 mmHg in spite of conservative measures) or pulmonary edema (O2 saturation <90% by pulse oximetry and the presence of rales or crackles)
- Cardiac arrest requiring chest compression or resuscitation
- Anatomical complications limit capacity to place PICSO Impulse device or achieve stable catheter placement or occlude coronary sinus
- Known renal disease (GFR < 30 mL/min/1.73m2) or dialysis
- History of stroke, TIA or reversible ischemic neurological disease within last 6 months
- Left bundle branch block
- Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
- Presence of any lead in the coronary sinus
- Active or treated malignancies in the last 12 months
- Previous coronary artery bypass graft surgery
- Known severe anemia (Hgb < 10 g/dL or < 6.2 mmol/L)
- Known platelet count < 100,000, known coagulopathy or bleeding diathesis, or unwilling to accept transfusions
- Participation in another ongoing clinical study
- Women of child-bearing age
- Non-cardiac comorbidities and life expectancy < 1 year
- Legal incompetence
- A condition that, in the opinion of the Investigator, precludes participation, including compliance with all follow-up procedures
- No dependents neither to the sponsor nor to the investigator
Sites / Locations
- Academic Medical Center - University of Amsterdam
- Amphia Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PICSO
Arm Description
PICSO treatment for 90 minutes
Outcomes
Primary Outcome Measures
Successful delivery of PICSO treatment
Assessment of the feasibiity of PICSO in STEMI patients defined as the successful elivery of the PICSO catheter and the successful administration of PICSO treatment for 90 minutes
Secondary Outcome Measures
MRI measurement of infarct size
Infarct size assessed by cardiac MRI between 2-5 days post primary PCI and again at 120 days follow up
Assessment of left ventricular function
Left ventricular function assessed by echocardiography between 2-5 days after primary PCI and at 120 days
Assessment of microvascular perfusion
Microvascular perfusion assessed by cardiac MRI between 2-5 days after primary PCI and at 120 days
Resolution of ST-segment elevation
Occurrence of complete resolution of ST-segment elevation 30, 60, 90 and 120 minutes after last contrast injection prior to PICSO placement procedure on 24 hour continuous 12 lead ECG Holter monitor recording
Measurement of ST segment time curve area
ST segment time curve area for the first 3 hours on 24 hour continuous 12 lead ECG Holter monitor recording.
Number of adverse events
Safety endpoints recorded are Major Adverse Cardiac Events (MACE), Major Adverse Cardiac and Cerebrovascular Events (MACCE), net adverse clinical events (MACE and bleeding), Serious and non serious Adverse Device Events ((S)ADE) rates
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01493037
Brief Title
PICSO in Patients With STEMI Treated by Primary Percutaneous Coronary Intervention
Acronym
pRAMSES
Official Title
Pressure Controlled Intermittent Coronary Sinus Occlusion in Patients With ST Segment Elevation Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention: Safety and Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Miracor Medical SA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A prospective multi-center study in which patients with an acute heart attack (in the left anterior descending artery) with ECG changes (ST segment elevation) receive angioplasty followed by stent placement and 90 minutes of PICSO treatment. This is a proof of concept study designed to document the safety and feasibility of the Pressure Controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation (STEMI) Myocardial Infarction
Keywords
STEMI, PICSO, Coronary Sinus, Involving Left Anterior Descending Coronary Artery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PICSO
Arm Type
Other
Arm Description
PICSO treatment for 90 minutes
Intervention Type
Device
Intervention Name(s)
PICSO (Pressure-controlled Intermittent Coronary Occlusion
Other Intervention Name(s)
PICSO Impulse Catheter, PICSO Impulse Console
Intervention Description
The PICSO catheter has a balloon which is placed in the coronary sinus via the femoral vein. The balloon is inflated and deflated at intervals calculated by an algorithm and adjusted according to the patient's own coronary sinus pressure plateau.
Primary Outcome Measure Information:
Title
Successful delivery of PICSO treatment
Description
Assessment of the feasibiity of PICSO in STEMI patients defined as the successful elivery of the PICSO catheter and the successful administration of PICSO treatment for 90 minutes
Time Frame
90 minutes
Secondary Outcome Measure Information:
Title
MRI measurement of infarct size
Description
Infarct size assessed by cardiac MRI between 2-5 days post primary PCI and again at 120 days follow up
Time Frame
4 months
Title
Assessment of left ventricular function
Description
Left ventricular function assessed by echocardiography between 2-5 days after primary PCI and at 120 days
Time Frame
4 months
Title
Assessment of microvascular perfusion
Description
Microvascular perfusion assessed by cardiac MRI between 2-5 days after primary PCI and at 120 days
Time Frame
4 months
Title
Resolution of ST-segment elevation
Description
Occurrence of complete resolution of ST-segment elevation 30, 60, 90 and 120 minutes after last contrast injection prior to PICSO placement procedure on 24 hour continuous 12 lead ECG Holter monitor recording
Time Frame
24 hours
Title
Measurement of ST segment time curve area
Description
ST segment time curve area for the first 3 hours on 24 hour continuous 12 lead ECG Holter monitor recording.
Time Frame
3 hours
Title
Number of adverse events
Description
Safety endpoints recorded are Major Adverse Cardiac Events (MACE), Major Adverse Cardiac and Cerebrovascular Events (MACCE), net adverse clinical events (MACE and bleeding), Serious and non serious Adverse Device Events ((S)ADE) rates
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
First time anterior STEMI defined by the following:
Symptoms of myocardial ischemia > 30 minutes and < 12 hours
ST-segment elevation > 1mm (> 0.1 mV) in two contiguous precordial leads in the anterior territory on a 12-lead ECG
Uncomplicated PCI of a LAD culprit lesion (defined as angioplasty followed by stent placement or direct stenting without the occurrence of an adverse event(s) that would preclude further study participation, such as major bleeding, perforation, hypotension, pulmonary edema or instability that in the judgement of the investigator preclude participation in the trial)
Exclusion Criteria:
Younger than 18 years of age
Hospitalization with a primary diagnosis of acute myocardial infarction (AMI) previously or has evidence of previous Q-wave infarct
Left main coronary artery culprit lesion
Additional stenosis in the LAD for which PCI or CABG is likely to be needed in the next 6 months and which is not treated during the index procedure
Cardiogenic shock (systolic blood pressure ≤90 mmHg in spite of conservative measures) or pulmonary edema (O2 saturation <90% by pulse oximetry and the presence of rales or crackles)
Cardiac arrest requiring chest compression or resuscitation
Anatomical complications limit capacity to place PICSO Impulse device or achieve stable catheter placement or occlude coronary sinus
Known renal disease (GFR < 30 mL/min/1.73m2) or dialysis
History of stroke, TIA or reversible ischemic neurological disease within last 6 months
Left bundle branch block
Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
Presence of any lead in the coronary sinus
Active or treated malignancies in the last 12 months
Previous coronary artery bypass graft surgery
Known severe anemia (Hgb < 10 g/dL or < 6.2 mmol/L)
Known platelet count < 100,000, known coagulopathy or bleeding diathesis, or unwilling to accept transfusions
Participation in another ongoing clinical study
Women of child-bearing age
Non-cardiac comorbidities and life expectancy < 1 year
Legal incompetence
A condition that, in the opinion of the Investigator, precludes participation, including compliance with all follow-up procedures
No dependents neither to the sponsor nor to the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan J Piek, Professor
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center - University of Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Amphia Hospital
City
Breda
Country
Netherlands
12. IPD Sharing Statement
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PICSO in Patients With STEMI Treated by Primary Percutaneous Coronary Intervention
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