Cardiogenic Shock Working Group Registry (CSWG)

February 21, 2024 updated by: Tufts Medical Center
The Cardiogenic Shock Working Group is a multicenter registry where we collect de-identified clinical variables from the medical records and follow-up phone calls of shock patients from multiple institutions and centralize this data to a single registry for analysis of clinical outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Cardiogenic Shock Working Group is an Academic Research Consortium involving multiple medical centers within the United States and includes a multicenter registry for patients with cardiogenic shock. De-identified clinical variables are collected from medical records and follow-up phone calls. There is currently no central database for cardiogenic shock, therefore analysis of cardiogenic shock on a larger scale is limited. A goal of the Cardiogenic Shock Working Group is to create a centralized registry, compiled of data from multiple institutions, to analyze clinical outcomes. The Cardiogenic Shock Working Group Registry will include a retrospective arm, where data is collected during the course of the hospital stay, and a prospective arm, where long-term outcomes will be assessed.

Study Type

Observational

Enrollment (Estimated)

5000

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

Study Locations

  • United States
    • Florida
      • Weston, Florida, United States, 33331
        • Recruiting
        • Cleveland Clinic Florida
        • Contact:
          • Jaime Hernandez-Montfort, MD MPH
        • Principal Investigator:
          • Jaime Hernandez-Montfort, MD MPH
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Medicine
        • Principal Investigator:
          • Esther Vorovich
        • Contact:
          • Esther Vorovich, MD
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Chicago
        • Contact:
          • Sandeep Nathan, MD
        • Principal Investigator:
          • Sandeep Nathan, MD
    • Maine
      • Portland, Maine, United States, 04102
        • Recruiting
        • Maine Medical Center
        • Contact:
          • Andrew Schwartzman, MD
        • Principal Investigator:
          • Andrew Schwartzman, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
          • Arthur R Garan
        • Principal Investigator:
          • Arthur R Garan, MD
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Principal Investigator:
          • Navin Kapur, MD
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack Meridian Health
        • Principal Investigator:
          • Haroon Faraz, MD
        • Contact:
          • Haroon Faraz, MD
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
          • Justin Fried, MD
        • Principal Investigator:
          • Justin Fried, MD
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence St. Vincent Heart Clinic
        • Principal Investigator:
          • Jacob Abraham, MD
        • Contact:
          • Jacob Abraham, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
          • Manreet Kanwar, MD
        • Principal Investigator:
          • Manreet Kanwar, MD
      • Pittsburgh, Pennsylvania, United States, 15261
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
          • Gavin Hickey, MD
        • Principal Investigator:
          • Gavin Hickey, MD
    • Texas
      • Dallas, Texas, United States, 75201
        • Recruiting
        • Baylor Scott & White Advanced Heart Failure Clinic
        • Contact:
          • Detlef Wencker, MD
        • Principal Investigator:
          • Detlef Wencker, MD
      • Galveston, Texas, United States, 77555
        • Recruiting
        • University of Texas Medical Branch
        • Contact:
          • Wissam Khalife, MD
        • Contact:
          • Wissam Khalife
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Contact:
          • : Ju H Kim, MD
        • Principal Investigator:
          • Ju H Kim, MD
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Health System
        • Contact:
          • Shashank Sinha, MD, MSc
        • Principal Investigator:
          • Shashank Sinha, MD, MSc
    • Washington
      • Seattle, Washington, United States, 98195-9472
        • Recruiting
        • University of Washington Medical Center
        • Principal Investigator:
          • Claudius Mahr, DO
        • Contact:
          • Claudius Mahr, DO

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People who are 18 or older who have an official diagnosis of cardiogenic shock.

Description

Inclusion Criteria:

  • Patients must have cardiogenic shock.

Cardiogenic shock is defined by at least one of the two categories below:

  1. At least 2 of the following concurrently at any point during the index hospitalization:

    • Cardiac Index < 2.2
    • PAPI < 1.0
    • Cardiac Power Output ≤ 0.6
    • MAP < 60mmHg or a >30mmHg drop in MAP from baseline
    • SBP < 90mmHg or a >30mmHg drop in SBP from baseline
    • Pulse > 100
  2. Require at least one acute mechanical circulatory support device, vasopressor or inotrope to maintain values above the above target.

Post-cardiotomy patients must meet the inclusion criteria 72 hours after their surgery to be included in this registry.

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: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiogenic Shock Patients

Cardiogenic Shock patients eligible for this study are defined by at least one of the two categories below.

  1. Patients have at least 2 of the following concurrently at any point during the index hospitalization: MAP < 60mmHg or a >30mmHg drop in MAP from baseline, SBP < 90mmHg or a >30mmHg drop in SBP from baseline, Pulse > 100, Cardiac Index < 2.2, Cardiac Power Output ≤ 0.6 or PAPI < 1.0.
  2. Patients require the use of at least 1 vasopressor, inotrope or acute mechanical circulatory support device to maintain values above the above targets.
Drug: Vasopressor
The vasopressors include phenylephrine, norepinephrine, epinephrine, dopamine and vasopressin.
Drug: Inotrope
Inotropes include dobutamine and milrinone.
Device: Acute Mechanical Circulatory Support Devices
Acute Mechanical Circulatory Support devices include ECMO (VV), ECMO (VA), Impella CP, Impella 2.5, Impella 5.0, Impella 5.5, Impella RP, IABP, Centrimag, Tandem Heart and ProTek Duo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Mortality
Time Frame: 30 days after discharge
Death in subjects during the time frame.
30 days after discharge
Rate of Mortality
Time Frame: 1 year after discharge
Death in subjects during the time frame.
1 year after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Re-hospitalization
Time Frame: 30 day after discharge
We will be observing if patient was hospitalized again during the 1 year-time frame. We will collect information on surgeries and interventions during the course of rehospitalization.
30 day after discharge
Rate of Re-hospitalization
Time Frame: 1 year after discharge
We will be observing if patient was hospitalized again during the 1 year-time frame. We will collect information on surgeries and interventions during the course of rehospitalization.
1 year after discharge
New York Heart Association (NYHA) Class
Time Frame: 30 day after discharge
NYHA Classification provides a way to classify the stages of heart failure. Class I- No symptoms and no limitation in ordinary physical activity Class II- Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV - Severe limitations
30 day after discharge
New York Heart Association (NYHA) Class
Time Frame: 1 year after discharge
NYHA Classification provides a way to classify the stages of heart failure. Class I- No symptoms and no limitation in ordinary physical activity Class II- Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV - Severe limitations
1 year after discharge

Collaborators and Investigators

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

Sponsor

Tufts Medical Center

Collaborators

Boston Scientific Corporation
Abbott
Abiomed Inc.
Getinge Group

Investigators

  • Study Director: Reshad Garan, MD, Beth Israel Deaconess Medical Center
  • Study Director: Claudius Mahr, DO, University of Washington
  • Study Director: Jaime Hernandez-Montfort, MD, Cleveland Clinic Foundation-Florida
  • Study Director: Daniel Burkhoff, MD PhD, CardioVascular Research Foundation

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)

December 4, 2017

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

December 7, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12670

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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