Recruiting

Observational Study

Sponsor:

Tufts Medical Center

Code:

NCT04682483

Conditions

Cardiogenic Shock

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vasopressor

Inotrope

Acute Mechanical Circulatory Support Devices

Study Details

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.

Conditions

Cardiogenic Shock

Study ID

NCT04682483

Start date

Dec 4, 2017

Status verified date

Jun, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

Cardiogenic Shock Patients

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.

Interventions

Vasopressor

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

Inotrope

Inotropes include dobutamine and milrinone.

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.

Primary outcome measure

  • Rate of Mortality [ Time Frame: 30 days after discharge ]
  • Rate of Mortality [ Time Frame: 1 year after discharge ]

Central Contacts and Locations

Central contacts

Navin K Kapur, MD

6176368252nkapur@tuftsmedicalcenter.org

Locations

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Principal Investigator:

Jaime Hernandez-Montfort, MD MPH

Northwestern Medicine

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Esther Vorovich

University of Chicago

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

Sandeep Nathan, MD

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Principal Investigator:

Andrew Schwartzman, MD

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Navin K Kapur, MD

6176366140nkapur@tuftsmedicalcenter.org

Principal Investigator:

Navin Kapur, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Arthur R Garan, MD

Hackensack Meridian Health

Recruiting

Hackensack, New Jersey, United States, 07601

Principal Investigator:

Haroon Faraz, MD

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Justin Fried, MD

Providence St. Vincent Heart Clinic

Recruiting

Portland, Oregon, United States, 97225

Principal Investigator:

Jacob Abraham, MD

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Principal Investigator:

Manreet Kanwar, MD

University Of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15261

Principal Investigator:

Gavin Hickey, MD

Baylor Scott & White Advanced Heart Failure Clinic

Recruiting

Dallas, Texas, United States, 75201

Principal Investigator:

Detlef Wencker, MD

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Ju H Kim, MD

Inova Health System

Recruiting

Falls Church, Virginia, United States, 22042

Principal Investigator:

Shashank Sinha, MD, MSc

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195-9472

Principal Investigator:

Claudius Mahr, DO

More Information

Sponsor

Tufts Medical Center

Last update posted

Jun 6, 2025

Last verified

Jun, 2025

Keywords

  • Cardiogenic Shock
  • mechanical circulatory support
  • hemodynamics
  • heart failure
  • acute myocardial infarction
  • registry
  • critical care
  • clinical outcomes research

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Tufts Medical Center on 2025-06-06.