Registry for Cardiogenic Shock: Utility and Efficacy of Device Therapy

NCT02790242 | Terminated DMC

• 1 other identifier: AAAM2960
• Study Type: observational
• Target: 1,089
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Heart Failure; Cardiogenic Shock

Keywords

Mechanical Circulatory Support Device (MCSD); ventricular Assist Device (VAD)

Outcome Measures

Primary Outcomes (1)

• 1-year survival post mechanical circulatory assist device implant

  12 months

Secondary Outcomes (3)

• survival to discharge post mechanical circulatory assist device implant

  until the enrolled patient is discharged. Expected to occur within 90 days of enrollment.

• 30-day survival post mechanical circulatory assist device implant

  30 days

• Number of adverse events during mechanical circulatory assist device support

  up to 30-days of weaning from the device.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• patients younger than 18 years of age.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (7)

University of Colarodo

Aurora, Colorado, 80045, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Newark Beth Israel Medical center

Newark, New Jersey, 07112, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related 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.

  PMID: 10460813 BACKGROUND

• 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.

  PMID: 22920912 BACKGROUND

• 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.

  PMID: 23352390 BACKGROUND

• 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.

  PMID: 22795459 BACKGROUND

• 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.

  PMID: 22920913 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Hiroo Takayama, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 3, 2016
• Study Start: November 1, 2013
• Primary Completion: February 11, 2020
• Study Completion: February 11, 2020
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)