CARDSUP - SWISS Circulatory Support Registry

Cardiogenic Shock Clinical Trial

— CARDSUP  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04117230
• Other study ID #: 4075
• Status: Recruiting
• Start date: August 9, 2019
• Est. completion date: August 31, 2034

Study information

• Verified date: May 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Lukas C Hunziker Munsch, PD
• Phone: 0041316322111
• Email: lukas.hunziker[@]insel.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. Device use is according to the decision of the treating physician and independent of this registry.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: August 31, 2034
• Est. primary completion date: August 31, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock, Cardiogenic

Locations

Country	Name	City	State
Switzerland	Universitätsspital Basel	Basel
Switzerland	Insel Gruppe AG, Inselspital Bern	Bern
Switzerland	Luzerner Kantonsspital	Luzern
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	Stadtspital Treimli	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of deceased participants at 1 month after cardiogenic shock	All-cause mortality at 30 days	30 days
Secondary	Statistical and medical analysis of major adverse cardiac and cerebrovascular events (MACCE) reported by participants	Major adverse cardiac and cerebrovascular events (MACCE)	6 months
Secondary	Statistical and medical analysis of vascular complications (VARC) reported by participants	Vascular complications (VARC)	6 months
Secondary	Statistical and medical analysis of vascular surgery needed by participants	Need for vascular surgery	6 months
Secondary	Statistical and medical analysis of bleeding complications (minor, major) reported by participants	Bleeding complications (minor, major)	6 months
Secondary	Implantation time of MCS-device	Implantation time of MCS-device	6 months
Secondary	Support time under MCS	Support time under MCS	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	Number of deceased participants at 6 month after cardiogenic shock	Mortality at 6 months	6 months