Registry for Cardiogenic Shock: Utility and Efficacy of Device Therapy

Heart Failure Clinical Trial

— RESCUE  

Official title:

Registry for Cardiogenic Shock: Utility and Efficacy of Device Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02790242
• Other study ID #: AAAM2960
• Status: Terminated
• Start date: November 2013
• Est. completion date: February 11, 2020

Study information

• Verified date: April 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1089
• Est. completion date: February 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiogenic Shock
• Heart Failure
• Shock
• Shock, Cardiogenic

Locations

Country	Name	City	State
United States	University of Colarodo	Aurora	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Columbia University Irving Medical Center	New York	New York
United States	Newark Beth Israel Medical center	Newark	New Jersey
United States	Washington University	Saint Louis	Missouri
United States	Westchester Medical Center	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34. doi: 10.1056/NEJM199908263410901. — View Citation

Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, Baldwin JT, Young JB. Fifth INTERMACS annual report: risk factor analysis from more than 6,000 mechanical circulatory support patients. J Heart Lung Transplant. 2013 Feb;32(2):141-56. doi: 10.1016/j.healun.2012.12.004. Erratum In: J Heart Lung Transplant. 2015 Oct;34(10):1356. Timothy Baldwin, J [corrected to Baldwin, J T]. — View Citation

Kirklin JK, Naftel DC, Pagani FD, Kormos RL, Stevenson L, Miller M, Young JB. Long-term mechanical circulatory support (destination therapy): on track to compete with heart transplantation? J Thorac Cardiovasc Surg. 2012 Sep;144(3):584-603; discussion 597-8. doi: 10.1016/j.jtcvs.2012.05.044. Epub 2012 Jul 15. — View Citation

O'Connor CM, Rogers JG. Evidence for overturning the guidelines in cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1349-50. doi: 10.1056/NEJMe1209601. Epub 2012 Aug 26. No abstract available. — View Citation

Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Bohm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year survival post mechanical circulatory assist device implant		12 months
Secondary	survival to discharge post mechanical circulatory assist device implant		until the enrolled patient is discharged. Expected to occur within 90 days of enrollment.
Secondary	30-day survival post mechanical circulatory assist device implant		30 days
Secondary	Number of adverse events during mechanical circulatory assist device support		up to 30-days of weaning from the device.