Acute Coronary SyndromeNCT02197325
PiCSO in ACS Study
A study testing PICSO in people with Acute Coronary Syndrome, run by Miracor Medical SA at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- PICSO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jan 2015to Nov 2017
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with first time symptoms of acute coronary syndrome (NSTEMI and STEMI)
- Culprit lesion in the LAD.
- Age range 25 - 75 years
Who cannot join
- 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
Show all 9Show fewer
- Pregnant Women
- Non-cardiac comorbidities and life expectancy < 1 year
- Use of warfarin
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Liverpool Heart and Chest Hospital
Liverpool
St Bartholomew's Hospital
London
Freeman Hospital
Newcastle
Northern General Hospital
Sheffield
About this study
Official title: Pressure Controlled Intermittent Coronary Sinus Occlusion (PiCSO) as an Adjunct to PCI in Acute Coronary Syndrome
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
Read the detailed description
The study is designed to evaluate the effect of PICSO treatment concomitant to or following primary PCI in patients with anterior non ST-segment Elevation Myocardial Infarction or ST-segment Elevation Myocardial Infarction, in patients with a culprit lesion in the LAD on Infarct Size and myocardial function. There will be 2 phases in this study.
- Phase 1: only NSTEMI patients will be recruited.
- Phase 2: only STEMI patients will be recruited.
Phase 1 During Phase 1 of the study only NSTEMI patients will be recruited. After having given informed consent the patient will be scheduled for pPCI and stent placement. On the day of the procedure the PICSO catheter will be placed as described below (refer to PICSO Impulse catheter placement). After the PICSO therapy is started the standard pPCI and stent placement is performed. PICSO is continued at a minimum of 30 minutes or as long as the standard pPCI and stent placement takes.
Phase 2 During Phase 2 of the study only STEMI patients will be recruited. Immediately after successful restoration of the blood flow the PICSO Impulse catheter is introduced and placed as described below (Refer to PICSO Impulse catheter placement).
After correct positioning of the PICSO Impulse catheter, the 0,032" guide wire is removed. PICSO therapy is initiated and continued until a PICSO Quantity of 1000 mmHg is reached or a maximum of 60 minutes active treatment whatever comes first. With PICSO in treatment mode, the stent is deployed.
The clinical outcome data collected will be based on the site standards of care for NSTEMI and acute STEMI. Examinations include but are not limited to physical assessments, cardiac markers, ECG, laboratory results, x-rays, angiograms, cMRI and echocardiography.
- Conditions
- Acute Coronary Syndrome
- Being tested
- PICSO
- Keywords
- NSTEMI and STEMI
- Medical subject headings
- Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICSODevice
Also called PICSO Impulse System
Pressure controlled Intermittent Coronary Pressure Occlusion
| Study group | Role | What they receive |
|---|---|---|
| PICSO | Active comparator | Participants 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 Receives: Device: PICSO |
| Parallel control | No intervention | Participants enrolled in will receive treatment based on the standard guidelines for treatment of a myocardial infarction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 4 months
Secondary outcomes (4)
Enzymatic Infarct Size
Peak Troponin level 12 hours after pPCI, in comparison with a matched non-PICSO parallel control group
Measured: 12 hours post PCI
Level of Microvascular Obstruction assessed by cardia MRI
Microvascular Obstruction assessed by cardiac MRI on 2-5 days post pPCI
Measured: 2-5 days post PCI
Absolute Infarct size assessment by cardiac MRI
Infarct size assessment by cardiac MRI (presented as % of Area at Risk, AAR, and % of LV) at 2-5 days and 120 ± 14 days post-primary PCI in comparison with a matched non-PICSO parallel control group.
Measured: baseline and 4 months
MACE
Occurrence of major adverse cardiac events (MACE) during follow-up
Measured: baseline to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJan 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miracor Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Azfar Zaman, Prof. Dr., Principal investigator, Freeman Hospital, Newcastle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197325
- Sponsor's protocol ID
- CIP2014-03
- Status last verified
- Mar 2019
- First submitted
- 16 Jul 2014
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Controlled Intermittent Coronary Sinus Occlusion (PiCSO) as an Adjunct to PCI in Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02197325
- Acronym / sponsor ID
- CIP2014-03
- Conditions
- Acute Coronary Syndrome
- Keywords
- NSTEMI and STEMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Miracor Medical SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 22 Jul 2014 (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.
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
Detailed description
The study is designed to evaluate the effect of PICSO treatment concomitant to or following primary PCI in patients with anterior non ST-segment Elevation Myocardial Infarction or ST-segment Elevation Myocardial Infarction, in patients with a culprit lesion in the LAD on Infarct Size and myocardial function. There will be 2 phases in this study.
- Phase 1: only NSTEMI patients will be recruited.
- Phase 2: only STEMI patients will be recruited.
Phase 1 During Phase 1 of the study only NSTEMI patients will be recruited. After having given informed consent the patient will be scheduled for pPCI and stent placement. On the day of the procedure the PICSO catheter will be placed as described below (refer to PICSO Impulse catheter placement). After the PICSO therapy is started the standard pPCI and stent placement is performed. PICSO is continued at a minimum of 30 minutes or as long as the standard pPCI and stent placement takes.
Phase 2 During Phase 2 of the study only STEMI patients will be recruited. Immediately after successful restoration of the blood flow the PICSO Impulse catheter is introduced and placed as described below (Refer to PICSO Impulse catheter placement).
After correct positioning of the PICSO Impulse catheter, the 0,032" guide wire is removed. PICSO therapy is initiated and continued until a PICSO Quantity of 1000 mmHg is reached or a maximum of 60 minutes active treatment whatever comes first. With PICSO in treatment mode, the stent is deployed.
The clinical outcome data collected will be based on the site standards of care for NSTEMI and acute STEMI. Examinations include but are not limited to physical assessments, cardiac markers, ECG, laboratory results, x-rays, angiograms, cMRI and echocardiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICSO | Active comparator | Device: PICSOParticipants 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 intervention | –Participants enrolled in will receive treatment based on the standard guidelines for treatment of a myocardial infarction. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with first time symptoms of acute coronary syndrome (NSTEMI and STEMI)
- Culprit lesion in the LAD.
- Age range 25 - 75 years
Key exclusion criteria (9 listed)
- 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.)
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 |
|---|---|---|
| PICSOAlso: PICSO Impulse SystemPressure controlled Intermittent Coronary Pressure Occlusion | Device | PICSO |
Primary outcome
Change in Infarct Size assessed by cardiac MRI
Time frame: baseline and 4 months
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
4 secondary outcomes
Enzymatic Infarct Size
Time frame: 12 hours post PCI
Level of Microvascular Obstruction assessed by cardia MRI
Time frame: 2-5 days post PCI
Absolute Infarct size assessment by cardiac MRI
Time frame: baseline and 4 months
MACE
Time frame: baseline to 4 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 18 Mar 2019.
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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.
Azfar Zaman, Prof. Dr. principal investigator
Freeman Hospital, Newcastle
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICSO in people with Acute Coronary Syndrome, run by Miracor Medical SA at 4 sites in United Kingdom.
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 3 inclusion and 9 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 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
Change in Infarct Size assessed by cardiac MRI (time frame: baseline and 4 months). 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 18 Mar 2019.