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NCT Number: NCT04682483

Cardiogenic Shock Working Group Registry

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Florida, Weston, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have cardiogenic shock.

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

  • 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
  • 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.

Treatment and study plan

Vasopressor

Drug

The vasopressors include phenylephrine, norepinephrine, epinephrine, dopamine and vasopressin.

Inotrope

Drug

Inotropes include dobutamine and milrinone.

Acute Mechanical Circulatory Support Devices

Device

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.

Primary outcomes

  1. Rate of Mortality

    Time frame: 30 days after discharge

    Death in subjects during the time frame.

  2. Rate of Mortality

    Time frame: 1 year after discharge

    Death in subjects during the time frame.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Navin K Kapur, MD

CONTACT

[email protected]

6176368252

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • Abbott
  • Abiomed Inc.
  • Boston Scientific Corporation
  • Getinge Group

Registry information

Acronym: CSWG

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2020
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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