Registry for Cardiogenic Shock: Utility and Efficacy of Device Therapy (RESCUE)

April 11, 2023 updated by: Columbia University
The purpose of this study is to gather information on patients who have heart failure and are eligible for one of the following two procedures: 1) mechanical support, i.e. ventricular assist device (VAD) or 2) heart transplant. the study seeks to determine which patient populations benefit from heart transplant or ventricular assist device. This will allow to offer the state-of-the-art care to the patients in heart failure.

Study Overview

Status

Terminated

Conditions

Detailed Description

Cardiogenic shock (CS) develops in the end stage of various etiologies of heart failure and continues to hold high mortality; ranging from 50 to 80%. Expert consensus recommends use of more powerful mechanical circulatory support device (MCSD) in this patient population; however, scientific evidence has been anecdotal relying on mostly single-center small case series and, more fundamentally, because there is no unified definition to grade the severity of the highly heterogeneous condition CS. Well-designed studies are warranted to precisely characterize the various "phenotypes" of CS as well as the role of MCSD in this condition with still excessive mortality.

This multicenter registry will be the first multicenter large-scale registry focused on mechanical circulatory support (MCS) therapy for CS. The fundamental goal of RESCUE is to advance the understanding and application of MCSD in order to improve the persistently dismal survival of patients with CS with the following intents:

  1. Elucidate current indication and outcomes of MCSD use in CS.
  2. Redefine CS with better description of this disease entity, which will allow better prediction of outcomes, selection of treatment strategy, and comparison and design of studies.
  3. Facilitate the refinement of patient selection to maximize outcomes with current and new device options.
  4. Improve and expedite new device clinical trials by providing historical control data.
  5. Develop consensus "best practice" guidelines to improve clinical management by reducing short and long-term complications of MCSD therapy.

Study Type

Observational

Enrollment (Actual)

1089

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colarodo
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Potential subjects include all adult patients who underwent evaluation for MCS for cardiogenic shock. Each adult patient who receives an MCSD at an institution will be screened according to the inclusion and exclusion criteria listed below.

Description

Inclusion Criteria:

  • Adult patients who receive any MCSD including Veno-Arterial Extracorporeal Membrane Oxygenation (VA ECMO), surgical VAD, and percutaneous VAD, used to treat CS on or after 9/30/10. Intraaortic balloon pumping (IABP) is not considered an MCSD in this Registry.
  • Adult patients who have signed informed consent. For patients who are too ill to give informed consent the health care proxy of the patient or next of kin will be approached for the informed consent.

Exclusion Criteria:

  • patients younger than 18 years of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1-year survival post mechanical circulatory assist device implant
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
survival to discharge post mechanical circulatory assist device implant
Time Frame: until the enrolled patient is discharged. Expected to occur within 90 days of enrollment.
until the enrolled patient is discharged. Expected to occur within 90 days of enrollment.
30-day survival post mechanical circulatory assist device implant
Time Frame: 30 days
30 days
Number of adverse events during mechanical circulatory assist device support
Time Frame: up to 30-days of weaning from the device.
up to 30-days of weaning from the device.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Hiroo Takayama, MD, PhD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

February 11, 2020

Study Completion (Actual)

February 11, 2020

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 2, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAM2960

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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