ST Elevation (STEMI) Myocardial InfarctionpRAMSESNCT01493037
PICSO in Patients With STEMI Treated by Primary Percutaneous Coronary Intervention
A study of ST Elevation (STEMI) Myocardial Infarction, run by Miracor Medical SA at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation (STEMI) Myocardial Infarction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesNetherlands
- Study dates
- Dec 2011to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Academic Medical Center - University of Amsterdam
Amsterdam, 1105 AZ
Amphia Hospital
Breda
About this study
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
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.
- Being tested
- PICSO (Pressure-controlled Intermittent Coronary Occlusion
- Keywords
- STEMI, PICSO, Coronary Sinus, Involving Left Anterior Descending Coronary Artery
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICSO (Pressure-controlled Intermittent Coronary OcclusionDevice
Also called PICSO Impulse Catheter, PICSO Impulse Console
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.
| Study group | Role | What they receive |
|---|---|---|
| PICSO | Other | PICSO treatment for 90 minutes Receives: Device: PICSO (Pressure-controlled Intermittent Coronary Occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 minutes
Secondary outcomes (6)
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
Measured: 4 months
Assessment of left ventricular function
Left ventricular function assessed by echocardiography between 2-5 days after primary PCI and at 120 days
Measured: 4 months
Assessment of microvascular perfusion
Microvascular perfusion assessed by cardiac MRI between 2-5 days after primary PCI and at 120 days
Measured: 4 months
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
Measured: 24 hours
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.
Measured: 3 hours
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation (STEMI) Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miracor Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan J Piek, Professor, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493037
- Sponsor's protocol ID
- CIP 2011-01
- Acronym
- pRAMSES
- Status last verified
- Jul 2014
- First submitted
- 13 Dec 2011
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01493037
- Acronym / sponsor ID
- pRAMSES / CIP 2011-01
- Keywords
- STEMI, PICSO, Coronary Sinus, Involving Left Anterior Descending Coronary Artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Miracor Medical SAIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2014 (actual)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PICSO | Other | Device: PICSO (Pressure-controlled Intermittent Coronary OcclusionPICSO treatment for 90 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First time anterior STEMI defined by the following:
- 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)
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICSO (Pressure-controlled Intermittent Coronary OcclusionAlso: PICSO Impulse Catheter, PICSO Impulse ConsoleThe 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. | Device | PICSO |
Primary outcome
Successful delivery of PICSO treatment
Time frame: 90 minutes
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
6 secondary outcomes
MRI measurement of infarct size
Time frame: 4 months
Assessment of left ventricular function
Time frame: 4 months
Assessment of microvascular perfusion
Time frame: 4 months
Resolution of ST-segment elevation
Time frame: 24 hours
Measurement of ST segment time curve area
Time frame: 3 hours
Number of adverse events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
Related trials for ST Elevation (STEMI) Myocardial Infarction
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan J Piek, Professor principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of ST Elevation (STEMI) Myocardial Infarction, run by Miracor Medical SA at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful delivery of PICSO treatment (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.