CSWG: Cardiogenic Shock Working Group Registry

Sponsor

Tufts Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04682483

Collaborator

Abbott (Industry), Boston Scientific Corporation (Industry), Abiomed Inc. (Industry), Getinge Inc. (Other)

5,000

Enrollment

Locations

89.9

Anticipated Duration (Months)

312.5

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiogenic Shock	Drug: Vasopressor Drug: Inotrope Device: Acute Mechanical Circulatory Support Devices

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Cardiogenic Shock Working Group Registry

Actual Study Start Date :

Dec 4, 2017

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Cardiogenic Shock Patients 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 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.

Arm

Intervention/Treatment

Cardiogenic Shock Patients

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

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.

Outcome Measures

Primary Outcome Measures

Rate of Mortality [30 days after discharge]
Death in subjects during the time frame.
Rate of Mortality [1 year after discharge]
Death in subjects during the time frame.

Secondary Outcome Measures

Rate of Re-hospitalization [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.
Rate of Re-hospitalization [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.
New York Heart Association (NYHA) Class [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
New York Heart Association (NYHA) Class [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Florida	Weston	Florida	United States	33331
2	Northwestern Medicine	Chicago	Illinois	United States	60611
3	University of Chicago	Chicago	Illinois	United States	60612
4	Maine Medical Center	Portland	Maine	United States	04102
5	Tufts Medical Center	Boston	Massachusetts	United States	02111
6	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
7	Hackensack Meridian Health	Hackensack	New Jersey	United States	07601
8	Columbia University Irving Medical Center	New York	New York	United States	10032
9	Providence St. Vincent Heart Clinic	Portland	Oregon	United States	97225
10	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
11	University Of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15261
12	Baylor Scott & White Advanced Heart Failure Clinic	Dallas	Texas	United States	75201
13	University of Texas Medical Branch	Galveston	Texas	United States	77555
14	Houston Methodist Hospital	Houston	Texas	United States	77030
15	Inova Health System	Falls Church	Virginia	United States	22042
16	University of Washington Medical Center	Seattle	Washington	United States	98195-9472

Sponsors and Collaborators

Tufts Medical Center
Abbott
Boston Scientific Corporation
Abiomed Inc.
Getinge Inc.

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