Cardiogenic ShockCARDSUPNCT04117230
CARDSUP - SWISS Circulatory Support Registry
An observational study of Cardiogenic Shock, run by Insel Gruppe AG, University Hospital Bern at 5 sites in Switzerland.
Trial summary
The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ECMO or Impella implantation at all included sites. All patients undergoing ECMO and/or IMPELLA implantation will be prospectively registered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- How many people
- 1,500 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 9 Aug 2019to 31 Aug 2034
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: In an all-comers design, every patient receiving an MCS will be included.
Who may be able to join
- Age > 18 years
- Medical indication for implantation of a peripheral cannulated VA-ECMO or microaxial flow pump (IMPELLA) or newer LV / LA-Ascending Aorta devices.
- Signed informed consent by patient or relative or waived consent by EC
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Switzerland5 sites, 5 recruiting
- Recruiting
Universitätsspital Basel
Basel, 4053
Gregor Leibundgut, Prof MD, 0041612652525, gregor.leibundgut@usb.ch
- Recruiting
Insel Gruppe AG, Inselspital Bern
Bern, 3010
Monika Fürholz, MD, 004131 632 21 11, monika.fuerholz@insel.ch
- Recruiting
Luzerner Kantonsspital
Lucerne, 3600
Florim Cuculi, PD MD, 0041412051111, florim.cuculi@luks.ch
- Recruiting
Kantonsspital Winterthur
Winterthur, 8400
Stefan Blöchlinger, PD MD PhD, 004152 266 21 21, stefan.bloechlinger@ksw.ch
- Recruiting
Stadtspital Treimli
Zurich, 8063
Gregor Fahrni, PD MD, 004144 416 11 11, gregor.fahrni@stadtspital.ch
About this study
Official title: Clinical Outcomes in Patients in Need of a Non-permanent Extracorporeal Cardiocirculatory Support System (Peripheral Extracorporeal Membrane Oxygenation (ECMO) or Axial Flow Pump IMPELLA)
The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ECMO or Impella implantation at all included sites. All patients undergoing ECMO and/or IMPELLA implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.
Read the detailed description
This prospective data collection is made up of an all-comers design, including all eligible consecutive patients receiving an Impella (2.5, 5, CP, or RP) or VA-ECMO device via femoral access who gave their consent (or, if not possible, their relative).
The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ECMO or Impella implantation at all included sites. All patients undergoing ECMO and/or IMPELLA implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.
- Conditions
- Cardiogenic Shock
- Medical subject headings
- Shock, Cardiogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of deceased participants at 1 month after cardiogenic shock
All-cause mortality at 30 days
Measured: 30 days
Secondary outcomes (9)
Statistical and medical analysis of major adverse cardiac and cerebrovascular events (MACCE) reported by participants
Major adverse cardiac and cerebrovascular events (MACCE)
Measured: 6 months
Statistical and medical analysis of vascular complications (VARC) reported by participants
Vascular complications (VARC)
Measured: 6 months
Statistical and medical analysis of vascular surgery needed by participants
Need for vascular surgery
Measured: 6 months
Statistical and medical analysis of bleeding complications (minor, major) reported by participants
Bleeding complications (minor, major)
Measured: 6 months
Implantation time of MCS-device
Implantation time of MCS-device
Measured: 6 months
Support time under MCS
Support time under MCS
Measured: 6 months
Analysis of New York Heart Association (NYHA) Classification for participants
The New York Heart Association (NYHA) Classification provides a way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain. Class I is defined as no symptoms and no limitation in ordinary physical activity worsening to Class IV defined as severe limitations.
Measured: 6 months
Modified rankin scale
Modified rankin scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological Disability. The scale ranges form 0-6 with 0 defined as no Symptoms and 5 being severe Symptoms and 6 defined as death.
Measured: 6 months
Number of deceased participants at 6 month after cardiogenic shock
Mortality at 6 months
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 posted7 Oct 2019
- Study start9 Aug 2019
- Primary completion31 Aug 2034 (estimated)
- Study completion31 Aug 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lukas C Hunziker Munsch, Prof MD, Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117230
- Sponsor's protocol ID
- 4075
- Acronym
- CARDSUP
- Status last verified
- Dec 2024
- First submitted
- 3 Oct 2019
- Last updated
- 6 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes in Patients in Need of a Non-permanent Extracorporeal Cardiocirculatory Support System (Peripheral Extracorporeal Membrane Oxygenation (ECMO) or Axial Flow Pump IMPELLA)
- ClinicalTrials.gov ID
- NCT04117230
- Acronym / sponsor ID
- CARDSUP / 4075
- Conditions
- Cardiogenic Shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 31 Aug 2034 (estimated)
- Study completion
- 31 Aug 2034 (estimated)
- First posted
- 7 Oct 2019 (actual)
- 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 project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ECMO or Impella implantation at all included sites. All patients undergoing ECMO and/or IMPELLA implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.
Detailed description
This prospective data collection is made up of an all-comers design, including all eligible consecutive patients receiving an Impella (2.5, 5, CP, or RP) or VA-ECMO device via femoral access who gave their consent (or, if not possible, their relative).
The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ECMO or Impella implantation at all included sites. All patients undergoing ECMO and/or IMPELLA implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In an all-comers design, every patient receiving an MCS will be included.
Key inclusion criteria (3 listed)
- Age > 18 years
- Medical indication for implantation of a peripheral cannulated VA-ECMO or microaxial flow pump (IMPELLA) or newer LV / LA-Ascending Aorta devices.
- Signed informed consent by patient or relative or waived consent by EC
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of deceased participants at 1 month after cardiogenic shock
Time frame: 30 days
All-cause mortality at 30 days
9 secondary outcomes
Statistical and medical analysis of major adverse cardiac and cerebrovascular events (MACCE) reported by participants
Time frame: 6 months
Statistical and medical analysis of vascular complications (VARC) reported by participants
Time frame: 6 months
Statistical and medical analysis of vascular surgery needed by participants
Time frame: 6 months
Statistical and medical analysis of bleeding complications (minor, major) reported by participants
Time frame: 6 months
Implantation time of MCS-device
Time frame: 6 months
Support time under MCS
Time frame: 6 months
Analysis of New York Heart Association (NYHA) Classification for participants
Time frame: 6 months
Modified rankin scale
Time frame: 6 months
Number of deceased participants at 6 month after cardiogenic shock
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
Related trials for Cardiogenic Shock
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Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingObservational study
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
AMI Cardiogenic Shock
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Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
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.
Lukas C Hunziker Munsch, Prof MD study chair
University of Bern
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock, run by Insel Gruppe AG, University Hospital Bern at 5 sites in Switzerland.
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 1 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: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lukas C Hunziker Munsch, Prof MD (0041316322111, lukas.hunziker@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of deceased participants at 1 month after cardiogenic shock (time frame: 30 days). 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 6 Dec 2024.