SafeTy and Outcome of contemPorary Treatment Strategies for Cardiogenic SHOCK (STOP-SHOCK)

September 29, 2021 updated by: PD Dr. Dirk Westermann, Universitätsklinikum Hamburg-Eppendorf

SafeTy and Outcome of contemPorary Treatment Strategies for Cardiogenic SHOCK - an International, Observational Registry

International, observational registry to investigate the outcome in patients with cardiogenic shock. The primary aim of this study is to investigate the clinical outcome of patients in cardiogenic shock.

Study Overview

Status

Recruiting

Conditions

Detailed Description

There is a focus on interventional therapies, mechanical circulatory support and new cardiovascular therapeutics in patients with cardiogenic shock (CS). The investigators will describe current practice in study sites including concomitant patients with CS. Therefore, the investigators will monitor drug therapies initiated, devices being utilized as well as outcome and side effect of possible interventions

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Benedikt Schrage, MD
  • Phone Number: +49 40 7410 18135
  • Email: b.schrage@uke.de

Study Contact Backup

Study Locations

  • Germany
      • Hamburg, Germany
        • Recruiting
        • University Heart Center
        • Contact:
          • Benedikt Schrage, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted to a tertiary care hospital.

Description

Inclusion Criteria:

  • Patients with cardiogenic shock treated at a tertiary care hospital.

Exclusion Criteria:

  • Age ≤17 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: Within 30 days after admission.
by registration office
Within 30 days after admission.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic events, bleeding events, heart failure, sepsis, dialysis.
Time Frame: Within 30 days after admission.
by survey, number of ischemic events, number of bleeding events, number of patients developing heart failure as well as heart failure severity (NYHA), patients developing terminal kidney failure requiring dialysis.
Within 30 days after admission.
All-cause mortality
Time Frame: Within 12 months after admission.
by registration office
Within 12 months after admission.
Ischemic events, bleeding events, heart failure, sepsis, dialysis.
Time Frame: Within 12 months after admission.
by survey, number of ischemic events, number of bleeding events, number of patients developing heart failure as well as heart failure severity (NYHA), patients developing terminal kidney failure requiring dialysis.
Within 12 months after admission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Dirk Westermann, MD, UHZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Anticipated)

December 31, 2030

Study Completion (Anticipated)

December 31, 2031

Study Registration Dates

First Submitted

October 14, 2017

First Submitted That Met QC Criteria

October 14, 2017

First Posted (Actual)

October 18, 2017

Study Record Updates

Last Update Posted (Actual)

October 7, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STOP-SHOCK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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