Cardiogenic Shock Working Group Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cardiogenic Shock Working Group Registry

Conditions
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Cardiogenic Shock

Intervention / Treatment
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* Drug: Vasopressor
* Drug: Inotrope
* Device: Acute Mechanical Circulatory Support Devices


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiogenic Shock Patients<br>Cardiogenic Shock patients eligible for this study are defined by at least one of the two categories below. 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. 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<br>* The vasopressors include phenylephrine, norepinephrine, epinephrine, dopamine and vasopressin.<br>Drug: Inotrope<br>* Inotropes include dobutamine and milrinone.<br>Device: Acute Mechanical Circulatory Support Devices<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Re-hospitalization | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiogenic Shock, mechanical circulatory support, hemodynamics, heart failure, acute myocardial infarction, registry, critical care, clinical outcomes research