Lower Silesia Cardiogenic Shock Initiative

NCT05465200 | Recruiting DMC

• 1 other identifier: WMU012021
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

LSCSI is a Hub\&Spoke project with the main aim to improve the outcome of patients with cardiogenic shock in Lower Silesia region, Poland. It consists of one "hub" which is Wroclaw University Hospital and eleven "spokes" which are eleven cardiology departments situated in Lower Silesian Voivodeship. The consortium have unified protocol defining which cardiogenic shock patient and when should be transferred to the "hub" for enhanced treatment options including durable mechanical circulatory support or heart transplant. The "hub" have 7/24 Shock Team on-site supplied with a protocol how to proceed with "spoke" transferred patients including decision making on which mechanical circulatory support implant with subsequent de-escalation or escalation pathway.

Conditions

Cardiogenic Shock

Keywords

Cardiogenic shock; ECMO; Heart transplant; Mechanical circulatory support; Impella

Outcome Measures

Primary Outcomes (1)

• 30-days all-cause mortality

  All-cause mortality

  30 days

Secondary Outcomes (1)

• 12-months mortality

  12 months

Interventions

Structured treatment of cardiogenic shock patients PROCEDURE

Creation of hub\&spoke structure which covers all Lower Silesian Voivodeship (Poland) for treatment of cardiogenic shock patients. Based on shared protocol patients are reported to "hub" by "spoke" and decision is made as for patient transfer or further treatment in the "spoke" facility. If decision on transfer is made, patient is further treated according to "hub" on site shock team protocol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

LSCSI is designed to treat cardiogenic shock which may develop during: 1. Acute coronary syndrome 2. Acute decompensated heart failure 3. Acute myocarditis 4. Acute or decompensated chronic valvular heart disease 5. Takotsubo cardiomyopathy 6. Peripartum cardiomyopathy 7. Acute pulmonary embolism

You may qualify if:

• Fulfilled definition of cardiogenic shock
• Age 18 - 60 years
• Shock duration below 24 hours

You may not qualify if:

• History of cardiac arrest with anoxemic brain injury
• Irreversible multiorgan failure
• End stage of chronic diseases other than heart failure
• Neoplastic disease
• Lack of vascular access

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Institute of Heart Disease of Wroclaw Medical University

Wroclaw, 50-556, Poland

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Central Study Contacts

Wiktor Kuliczkowski

CONTACT

+48717331112; wiktor.kuliczkowski@umed.wroc.pl

Mateusz Sokolski

CONTACT

+48717331112; mateusz.sokolski@umed.wroc.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Catheterization Laboratory

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 19, 2022
• Study Start: January 1, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

PL (1)