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Cardiogenic Shock Working Group Registry
NCT04682483 · Tufts Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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.
Eligibility criteria
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 design
Enrollment target: 5000 participants
Age groups: adult, older_adult
Timeline
Starts: 2017-12-04
Estimated completion: 2026-06-01
Last updated: 2025-06-06
Interventions
Drug: VasopressorDrug: InotropeDevice: Acute Mechanical Circulatory Support Devices
Primary outcomes
- • Rate of Mortality (30 days after discharge)
- • Rate of Mortality (1 year after discharge)
Sponsor
Tufts Medical Center · other
With: Abbott, Boston Scientific Corporation, Abiomed Inc., Getinge Group
Contacts & investigators
ContactNavin K Kapur, MD · contact · nkapur@tuftsmedicalcenter.org · 6176368252
InvestigatorReshad Garan, MD · study_director, Beth Israel Deaconess Medical Center
InvestigatorClaudius Mahr, DO · study_director, University of Washington
InvestigatorJaime Hernandez-Montfort, MD · study_director, Cleveland Clinic Foundation-Florida
All locations (16)
Cleveland Clinic FloridaRecruiting
Weston, Florida, United States
Northwestern MedicineRecruiting
Chicago, Illinois, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
Maine Medical CenterRecruiting
Portland, Maine, United States
Tufts Medical CenterRecruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Hackensack Meridian HealthRecruiting
Hackensack, New Jersey, United States
Columbia University Irving Medical CenterRecruiting
New York, New York, United States
Providence St. Vincent Heart ClinicRecruiting
Portland, Oregon, United States
Allegheny General HospitalRecruiting
Pittsburgh, Pennsylvania, United States
University Of Pittsburgh Medical CenterRecruiting
Pittsburgh, Pennsylvania, United States
Baylor Scott & White Advanced Heart Failure ClinicRecruiting
Dallas, Texas, United States
University of Texas Medical BranchRecruiting
Galveston, Texas, United States
Houston Methodist HospitalRecruiting
Houston, Texas, United States
Inova Health SystemRecruiting
Falls Church, Virginia, United States
University of Washington Medical CenterRecruiting
Seattle, Washington, United States