Myocardial InfarctionPhase 4NCT00314847
Comparison of Standard Treatment Versus Standard Treatment Plus Extracorporeal Life Support (ECLS) in Myocardial Infarction Complicated With Cardiogenic Shock
A Phase 4 study testing Extra-Corporeal Life Support -Impella 2.5 in people with Myocardial Infarction and Shock, Cardiogenic, run by University Hospital, Caen at 13 sites in France.
Trial summary
Cardiogenic shock is currently the main cause of death after myocardial infarction and 50% of deaths occur within the first 48 hours. To limit the extent of the myocardial necrosis is the primary objective of the treatment in this context. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction, Shock, Cardiogenic
- What is being tested?
- Extra-Corporeal Life Support -Impella 2.5
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 13 sitesFrance
- Study dates
- Jun 2005to Oct 2009
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myocardial infarction complicated with cardiogenic shock
- Patient without contraindication to IABP or ECLS-Impella
Who cannot join
- Patient with refractory cardiogenic shock
- Reperfusion > 24 hours after the pain begins
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Brest University Hospital
Brest, 29000
Caen University Hospital
Caen, 14000
Clermont-Ferrand University Hospital
Clermont-Ferrand, 63000
Hôpital de la Croix Rousse
Lyon, 69317
Hôpital de la Timone
Marseille, 13008
Paris Sud Cardiovascular Institute
Massy
Mulhouse Hospital
Mulhouse, 68000
Pitié-Salpétrière Hospital
Paris, 75013
Cochin Hospital
Paris
Hôpital Haut-Lévèque
Pessac, 33604
Hôpital Charles Nicolle
Rouen
Centre Cardiologique du Nord
Saint-Denis, 93207
Toulouse University Hospital
Toulouse, 31000
About this study
Official title: National Multicenter Randomized Trial, Comparing Two Treatments of Myocardial Infarction Complicated With Cardiogenic Shock: Standard Treatment vs Standard Treatment Plus ECLS (Extracorporeal Life Support)
Cardiogenic shock is currently the main cause of death after myocardial infarction and 50% of deaths occur within the first 48 hours. To limit the extent of the myocardial necrosis is the primary objective of the treatment in this context. The symptomatic treatment of the ventricular failure alone does not allow a reduction of mortality. The immediate prognosis is not significantly improved by the current standard of care, including early revascularisation and intra-aortic balloon counterpulsation.
In order to improve the immediate prognosis, it seems necessary to limit the irreversible myocardial lesions and the systemic inflammatory response induced by an extended myocardial infarction (complement activation, cytokines production, iNOS expression, etc.). These objectives may be reached by a more extended utilization and availability of circulatory assistance methods.
Read more
The investigators propose to compare, in a randomised multicenter study, two treatments of the myocardial infarction with cardiogenic shock among 44 patients:
Standard Treatment versus ECLS-Impella +/- standard treatment.
In June 2007, an amendment replaced the device ECMO by the use of Impella intra-thoracic pump.
This amendment has been approved by the Ethic Committee on July 7, 2007. In March 2009, a new amendment has been approved by the EC. This amendment allowed to revise the number of patients to enroll (reduced to 44) and this lead us to modify also the primary endpoint : variation of BNP levels between H0 and H24 (H0 defined as the nearest value of BNP level obtained before the randomization).Showing a more important BNP levels decrease in the experimental group compared to standard treatment group, the investigators obtain an indirect argument to show a superior efficacy of the tested strategy.
- Conditions
- Myocardial Infarction, Shock, Cardiogenic
- Being tested
- Extra-Corporeal Life Support -Impella 2.5
- Keywords
- Myocardial infarction, Cardiogenic shock, Extracorporeal Life Support-Impella
- Medical subject headings
- Myocardial Infarction, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-Corporeal Life Support -Impella 2.5Device
Also called IMPELLA LP 2.5
Percutaneous implantation of Impella pump for a duration of 3 days as a minimum and up to 7 days (recommended)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | IABP, inotropic drugs, antiplatelet agents according to site habits. |
| Experimental | Experimental | ECLS +/- IABP, inotropic drugs, antiplatelet agents according to site habits. Receives: Device: Extra-Corporeal Life Support -Impella 2.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of BNP levels between H0 and H24 (Ho is defined as the nearest value of BNP level before the randomization).
Measured: one month
Secondary outcomes (14)
BNP levels measured at H6, H12, H48 and H72.
Measured: one month
BNP level measured at H48 after assistance weaning.
Measured: one month
haemoglobin levels
Measured: one month
lactate levels
Measured: one month
creatinine levels
Measured: one month
Mortality at day 30 or Evolution to a refractory cardiogenic shock requiring an intra-thoracic ventricular assistance or an ECMO (ECLS-Impella group) and all types of ventricular assistance (IAPB group) or a cardiac graft within 30 days.
Measured: one month
Mortality at Day 30, at 6 months, at 1 year.
Measured: one year
Infarct size at 1 month and 4 months.
Measured: 4 months
Amines maximal dose
Measured: one month
Cardiologic treatments outside the hospital
Measured: one year
Assistance last
Measured: one month
mechanical ventilation last
Measured: one month
assistance weaning failure
Measured: one month
haemorrhagic, ischemic and septic complications.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study startJun 2005
- Study completionOct 2009
Why it stopped: The study was stopped prematurely due to insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Investigators
- Massimo Massetti, MD, Principal investigator, University Hospital, CaenRémi Sabatier, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314847
- Sponsor's protocol ID
- ECLS
- Status last verified
- Jul 2010
- First submitted
- 13 Apr 2006
- Last updated
- 2 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Multicenter Randomized Trial, Comparing Two Treatments of Myocardial Infarction Complicated With Cardiogenic Shock: Standard Treatment vs Standard Treatment Plus ECLS (Extracorporeal Life Support)
- ClinicalTrials.gov ID
- NCT00314847
- Acronym / sponsor ID
- ECLS
- Conditions
- Myocardial Infarction, Shock, Cardiogenic
- Keywords
- Myocardial infarction, Cardiogenic shock, Extracorporeal Life Support-Impella
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped prematurely due to insufficient recruitment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Oct 2009 (actual)
- First posted
- 17 Apr 2006 (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.
Cardiogenic shock is currently the main cause of death after myocardial infarction and 50% of deaths occur within the first 48 hours. To limit the extent of the myocardial necrosis is the primary objective of the treatment in this context. The symptomatic treatment of the ventricular failure alone does not allow a reduction of mortality. The immediate prognosis is not significantly improved by the current standard of care, including early revascularisation and intra-aortic balloon counterpulsation.
In order to improve the immediate prognosis, it seems necessary to limit the irreversible myocardial lesions and the systemic inflammatory response induced by an extended myocardial infarction (complement activation, cytokines production, iNOS expression, etc.). These objectives may be reached by a more extended utilization and availability of circulatory assistance methods.
The investigators propose to compare, in a randomised multicenter study, two treatments of the myocardial infarction with cardiogenic shock among 44 patients:
Standard Treatment versus ECLS-Impella +/- standard treatment.
In June 2007, an amendment replaced the device ECMO by the use of Impella intra-thoracic pump.
This amendment has been approved by the Ethic Committee on July 7, 2007. In March 2009, a new amendment has been approved by the EC. This amendment allowed to revise the number of patients to enroll (reduced to 44) and this lead us to modify also the primary endpoint : variation of BNP levels between H0 and H24 (H0 defined as the nearest value of BNP level obtained before the randomization).Showing a more important BNP levels decrease in the experimental group compared to standard treatment group, the investigators obtain an indirect argument to show a superior efficacy of the tested strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –IABP, inotropic drugs, antiplatelet agents according to site habits. |
| Experimental | Experimental | Device: Extra-Corporeal Life Support -Impella 2.5ECLS +/- IABP, inotropic drugs, antiplatelet agents according to site habits. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute myocardial infarction complicated with cardiogenic shock
- Patient without contraindication to IABP or ECLS-Impella
Key exclusion criteria (2 listed)
- Patient with refractory cardiogenic shock
- Reperfusion > 24 hours after the pain begins
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 |
|---|---|---|
| Extra-Corporeal Life Support -Impella 2.5Also: IMPELLA LP 2.5Percutaneous implantation of Impella pump for a duration of 3 days as a minimum and up to 7 days (recommended) | Device | Experimental |
Primary outcome
Variation of BNP levels between H0 and H24 (Ho is defined as the nearest value of BNP level before the randomization).
Time frame: one month
14 secondary outcomes
BNP levels measured at H6, H12, H48 and H72.
Time frame: one month
BNP level measured at H48 after assistance weaning.
Time frame: one month
haemoglobin levels
Time frame: one month
lactate levels
Time frame: one month
creatinine levels
Time frame: one month
Mortality at day 30 or Evolution to a refractory cardiogenic shock requiring an intra-thoracic ventricular assistance or an ECMO (ECLS-Impella group) and all types of ventricular assistance (IAPB group) or a cardiac graft within 30 days.
Time frame: one month
Mortality at Day 30, at 6 months, at 1 year.
Time frame: one year
Infarct size at 1 month and 4 months.
Time frame: 4 months
Amines maximal dose
Time frame: one month
Cardiologic treatments outside the hospital
Time frame: one year
Assistance last
Time frame: one month
mechanical ventilation last
Time frame: one month
assistance weaning failure
Time frame: one month
haemorrhagic, ischemic and septic complications.
Time frame: six months
Results and safety
The study was stopped early (reason given: The study was stopped prematurely due to insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2010.
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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.
Massimo Massetti, MD principal investigator
University Hospital, Caen
Rémi Sabatier, MD principal investigator
University Hospital, Caen
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Extra-Corporeal Life Support -Impella 2.5 in people with Myocardial Infarction and Shock, Cardiogenic, run by University Hospital, Caen at 13 sites in France.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 2 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was stopped prematurely due to insufficient recruitment). Results are not available in the source record.
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?
Variation of BNP levels between H0 and H24 (Ho is defined as the nearest value of BNP level before the randomization). (time frame: one month). 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 2 Aug 2010.