Cardiogenic ShockPhase 4ECLS-SHOCKNCT02544594
Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction
A Phase 4 study testing Extra-Corporal Life Support (ECLS) in people with Cardiogenic Shock, run by LMU Klinikum at 1 site in Germany.
Trial summary
This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Extra-Corporal Life Support (ECLS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to Mar 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with
- intended revascularization (PCI or CABG)
- Systolic blood pressure < 90 mmHg > 30 min or inotropes required to maintain pressure > 90 mmHg during systole
- Signs of left heart insufficiency and pulmonary congestion
- Signs of impaired organ perfusion with at least one of the following:
- Altered mental status
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- Cold, clammy skin
- Urine output <30 ml/h
- Serum lactate >2mmol/l
- Informed consent
Who cannot join
- Resuscitation > 60 minutes, ischemia > 10 minutes
- No intrinsic heart action
- Cerebral deficit with fixed dilated pupils
- Mechanical infarction complication
- Onset of shock > 12 h
- Severe peripheral artery disease
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- Aortic regurgitation > II.°
- Age > 80 years
- shock of other cause
- Other severe concomitant disease
- participation in another trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction
This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.
Read the detailed description
Cardiogenic shock is a serious complication of a myocardial infarction. Despite optimal treatment the mortality in patients with cardiogenic shock still exceeds 50% and surviving patients mostly suffer from severe heart failure due to an impaired cardiac function.
This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.
The main study hypothesis is to explore if additional treatment with ECLS preserves cardiac function (left ventricular ejection fraction) in patients with cardiogenic shock complicating acute myocardial infarction.
- Conditions
- Cardiogenic Shock
- Being tested
- Extra-Corporal Life Support (ECLS)
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-Corporal Life Support (ECLS)Device
Extra-Corporal Life Support (ECLS) (from Sorin)
| Study group | Role | What they receive |
|---|---|---|
| Extra-Corporal Life Support (ECLS) | Active comparator | Standard treatment plus Extra-Corporal Life Support (ECLS) (from Sorin) in patients with cardiogenic shock due to myocardial infarction. Receives: Device: Extra-Corporal Life Support (ECLS) |
| Standard treatment | No intervention | Standard treatment alone without Extra-Corporal Life Support (ECLS) in patients with cardiogenic shock due to myocardial infarction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (LVEF) on day 30
Measured: 30 days
Secondary outcomes (8)
30-day mortality
Measured: 30 days
Lactate levels
Measured: up to 48 hours
potentia hydrogenic levels
Measured: 48 hours
Length of mechanical ventilation
Measured: 30 days
Long-term mortality at 12 months
Measured: up to 12 months
Length of ICU stay
Measured: 30 days
Neurological Outcome (modified Rankin Scale)
Measured: up to 12 months
MACE (defined as cardiac death, non-fatal myocardial re-infarction, rehospitalisation for cardiac reasons and the need of CABG or PCI)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Best medical therapy versus best medical therapy + ECLS in the treatment of cardiogenic shock complicating acute myocardial infarction
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Stefan Brunner, LMU Klinikum
- Investigators
- Stefan Brunner, MD, Principal investigator, Munich University HospitalSteffen Massberg, MD, Study chair, Munich University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544594
- Sponsor's protocol ID
- GE IDE MucM001-15
- Acronym
- ECLS-SHOCK
- Status last verified
- Oct 2019
- First submitted
- 2 Sep 2015
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Brunner S, Guenther SPW, Lackermair K, Peterss S, Orban M, Boulesteix AL, Michel S, Hausleiter J, Massberg S, Hagl C. Extracorporeal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction. J Am Coll Cardiol. 2019 May 14;73(18):2355-2357. doi: 10.1016/j.jacc.2019.02.044. No abstract available.
PubMed 31072581
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02544594
- Acronym / sponsor ID
- ECLS-SHOCK / GE IDE MucM001-15
- Conditions
- Cardiogenic Shock
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 9 Sep 2015 (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.
This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.
Detailed description
Cardiogenic shock is a serious complication of a myocardial infarction. Despite optimal treatment the mortality in patients with cardiogenic shock still exceeds 50% and surviving patients mostly suffer from severe heart failure due to an impaired cardiac function.
This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.
The main study hypothesis is to explore if additional treatment with ECLS preserves cardiac function (left ventricular ejection fraction) in patients with cardiogenic shock complicating acute myocardial infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Best medical therapy versus best medical therapy + ECLS in the treatment of cardiogenic shock complicating acute myocardial infarction
| Arm | Type | Receives |
|---|---|---|
| Extra-Corporal Life Support (ECLS) | Active comparator | Device: Extra-Corporal Life Support (ECLS)Standard treatment plus Extra-Corporal Life Support (ECLS) (from Sorin) in patients with cardiogenic shock due to myocardial infarction. |
| Standard treatment | No intervention | –Standard treatment alone without Extra-Corporal Life Support (ECLS) in patients with cardiogenic shock due to myocardial infarction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with
- intended revascularization (PCI or CABG)
- Systolic blood pressure < 90 mmHg > 30 min or inotropes required to maintain pressure > 90 mmHg during systole
- Signs of left heart insufficiency and pulmonary congestion
- Signs of impaired organ perfusion with at least one of the following:
Key exclusion criteria (11 listed)
- Resuscitation > 60 minutes, ischemia > 10 minutes
- No intrinsic heart action
- Cerebral deficit with fixed dilated pupils
- Mechanical infarction complication
- Onset of shock > 12 h
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-Corporal Life Support (ECLS)Extra-Corporal Life Support (ECLS) (from Sorin) | Device | Extra-Corporal Life Support (ECLS) |
Primary outcome
Left ventricular ejection fraction (LVEF) on day 30
Time frame: 30 days
8 secondary outcomes
30-day mortality
Time frame: 30 days
Lactate levels
Time frame: up to 48 hours
potentia hydrogenic levels
Time frame: 48 hours
Length of mechanical ventilation
Time frame: 30 days
Long-term mortality at 12 months
Time frame: up to 12 months
Length of ICU stay
Time frame: 30 days
Neurological Outcome (modified Rankin Scale)
Time frame: up to 12 months
MACE (defined as cardiac death, non-fatal myocardial re-infarction, rehospitalisation for cardiac reasons and the need of CABG or PCI)
Time frame: up to 12 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 14 Oct 2019.
- Derived from this study: PubMed 31072581Brunner S, Guenther SPW, Lackermair K, Peterss S, Orban M, Boulesteix AL, Michel S, Hausleiter J, Massberg S, Hagl C. Extracorporeal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction. J Am Coll Cardiol. 2019 May 14;73(18):2355-2357. doi: 10.1016/j.jacc.2019.02.044. No abstract available.
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Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
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Cardiogenic Shock Working Group Registry
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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.
Stefan Brunner, MD principal investigator
Munich University Hospital
Steffen Massberg, MD study chair
Munich University Hospital
1 site 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-Corporal Life Support (ECLS) in people with Cardiogenic Shock, run by LMU Klinikum at 1 site in Germany.
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 10 inclusion and 11 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 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 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?
Left ventricular ejection fraction (LVEF) on day 30 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02544594, which also lists 1 linked publication.
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 14 Oct 2019.