An observational study in Cardiogenic Shock, sponsored by Tufts Medical Center. Recruiting at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Tufts Medical Center · Observational
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.
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.
277 studies on the registry are indexed under Shock, Cardiogenic; 127 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 200 across 142 observational studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →Tufts Medical Center is the lead sponsor of 194 studies on the registry; 28 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 16 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
People who are 18 or older who have an official diagnosis of cardiogenic shock.
Inclusion Criteria:
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:
Post-cardiotomy patients must meet the inclusion criteria 72 hours after their surgery to be included in this registry.
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 · Drug: Inotrope · Device: Acute Mechanical Circulatory Support Devices
The vasopressors include phenylephrine, norepinephrine, epinephrine, dopamine and vasopressin.
Inotropes include dobutamine and milrinone.
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.
Rate of Mortality
Death in subjects during the time frame.
Time frame: 30 days after discharge
Rate of Mortality
Death in subjects during the time frame.
Time frame: 1 year 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 1 year after discharge
Plan to share: No
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