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REASON 1 Trial: Sonography in Cardiac Arrest

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University of Massachusetts, Worcester
Sponsor:
Collaborators:
North Shore University Hospital
New York University School of Medicine
Mount Sinai Hospital, New York
Washington University School of Medicine
University of New Mexico
Advocate Health Care
University of California, Irvine
University of Utah
Carolinas Medical Center
Emory University
Louisiana State University Health Sciences Center in New Orleans
Duke University
Brigham and Women's Hospital
Massachusetts General Hospital
Rhode Island Hospital
Christiana Care Health Services
George Washington University
Kingston General Hospital
University of Ottawa
Jewish General Hospital
Horizon Health Network
York Hospitals
Boston Medical Center
Indiana University
Yale University
Queen's Medical Centre
University of Hawaii
Stanford University
Information provided by (Responsible Party):
Romolo Gaspari, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01446471
First received: September 9, 2011
Last updated: November 7, 2014
Last verified: November 2014
  Purpose

The aim of this study is to investigate the predictive value of the presence or absence of cardiac activity by bedside ultrasound during cardiac arrest. The investigators anticipate based on previous research that patients who suffer a cardiac arrest and have cardiac activity on bedside ultrasound will have a greater chance of surviving to hospital admission. The investigators hypothesis is that the mortality rate in patients in cardiac arrest with no cardiac activity by ultrasound will have a mortality rate of 100%.


Condition
Cardiac Arrest
Pulseless Electrical Activity
Asystole

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: REASON 1 Trial: Sonography in Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Number of patients that survive to Hospital Discharge [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Participants will be followed for the duration of hospital stay, an expected average of up to 12 months. The time frame is an estimate based on previous research. Patients could survive hours to days to weeks or months.


Secondary Outcome Measures:
  • The number of patients that demonstrate a Return of Spontaneous Circulation [ Time Frame: Up to 60 Minutes - ] [ Designated as safety issue: No ]
    Participants will be followed until a demonstrated return of spontaneous circulation (i.e. regain a pulse and blood pressure) is present - an expected average of up to 60 minutes. The time frame is an estimate based on previous research but is in the order of minutes.

  • The number of patients that survive to hospital admission [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
    Surviving participants will be followed to hospital admission- an expected average of up to 24 hours. The time frame is an estimate based on previous research. Patients could survive minutes to hours before they are admitted.


Estimated Enrollment: 1000
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiac Arrest
Patients in Cardiac Arrest will be enrolled

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients in cardiac arrest

Criteria

Inclusion Criteria:

  • Patients in cardiac arrest with no pulse

Exclusion Criteria:

  • Patients with isolated ventricular fibrillation as their cardiac rhythm at the time of presentation
  • Traumatic cardiopulmonary arrest
  • Ultrasound system or physician experienced in bedside cardiac ultrasound not available
  • Resuscitative efforts halted due to end of life decisions or designations
  • Attending physician of record declines enrollment of patient
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446471

Contacts
Contact: Romolo Gaspari, MD, PhD 508-334-7943 romolo.gaspari@umassmemorial.org

Locations
United States, Delaware
Christiana Health Care Recruiting
Newark, Delaware, United States
Contact: Jason Nomura, MD       jnomura@comcast.net   
Principal Investigator: Jason Nomura, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
Contact: Vicki Nobel, MD       vnoble@partners.org   
Principal Investigator: Vicki Noble, MD         
UMASS Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Virginia Mangolds, NP    508-421-1400    virginia.mangolds@umassmemorial.org   
Principal Investigator: Romolo Gaspari, MD, PhD         
United States, Missouri
Washington University Hospital Recruiting
St Louis, Missouri, United States
Contact: Dan Theodoro, MD       theodorod@wusm.wustl.edu   
Principal Investigator: Dan Theodoro, MD         
United States, New York
Northshore University Hospital Recruiting
Manhasset, New York, United States
Contact: Chris Raio, MD       Craio7@gmail.com   
Principal Investigator: Christopher Raio, MD         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States
Contact: Anthony Weekes, MD       anthony.weekes@carolinashealthcare.org   
Principal Investigator: Anthony Weekes, MD         
Canada
University of Ottowa Recruiting
Ottowa, Canada
Contact: Micheal Woo, MD       mwoo@ottawahospital.on.ca   
Principal Investigator: Michael Woo         
Sponsors and Collaborators
University of Massachusetts, Worcester
North Shore University Hospital
New York University School of Medicine
Mount Sinai Hospital, New York
Washington University School of Medicine
University of New Mexico
Advocate Health Care
University of California, Irvine
University of Utah
Carolinas Medical Center
Emory University
Louisiana State University Health Sciences Center in New Orleans
Duke University
Brigham and Women's Hospital
Massachusetts General Hospital
Rhode Island Hospital
Christiana Care Health Services
George Washington University
Kingston General Hospital
University of Ottawa
Jewish General Hospital
Horizon Health Network
York Hospitals
Boston Medical Center
Indiana University
Yale University
Queen's Medical Centre
University of Hawaii
Stanford University
Investigators
Principal Investigator: Romolo Gaspari, MD, PhD UMASS Memorial Medical Center
  More Information

No publications provided

Responsible Party: Romolo Gaspari, Director, Division of Emergency Ultrsound, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01446471     History of Changes
Other Study ID Numbers: REASON01
Study First Received: September 9, 2011
Last Updated: November 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Bedside Ultrasound
Point of care ultrasound
cardiac arrest

Additional relevant MeSH terms:
Heart Arrest
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014