NCT02738099

Brief Summary

Method: Single center, prospective, non-randomized, unblinded case series of all patients presenting with a cardiac arrest. The proposed study will collect data on all comatose patients presenting with cardiac arrest. The primary end point is death from any cause at 30 days from admission. Significance: Develop criteria to guide an invasive strategy for comatose patients presenting with cardiac arrest, and so avoid ineffective or even futile therapy which carry its own significant risks for patients in the future. The criteria, in turn, can serve as the basis for a prospective, randomized trial in the future.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

4.1 years

First QC Date

April 11, 2016

Last Update Submit

May 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Death from any cause

    Death from any cause at 30 days from admission

    30 days

Study Arms (1)

Arrest from presume Cardiac etiology

Comatose patients following arrest of presumed cardiac etiology arriving to receiving facility within 12 hours of event.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Comatose patients presenting with cardiac arrest to the receiving facility within 12 hours of the event

You may qualify if:

  • Age greater than or equal to 18 years
  • Presumed cardiac etiology of arrest
  • GCS ≤ 819,20
  • Initial presentation to an outside facility or to the emergency room of the receiving facility.

You may not qualify if:

  • Presumed non-cardiac etiology of arrest including trauma, pulmonary embolus, sepsis, respiratory failure.
  • GCS \> 9
  • Transfer time from arrest to receiving facility greater than 12 hours
  • Cardiac arrest occurring after admission to either the outside facility or receiving facility.
  • Patient pronounced dead prior to arrival to the receiving facility emergency room.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Mary's MedicalCenter

Duluth, Minnesota, 55811, United States

Location

Related Publications (25)

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  • Mooney MR, Unger BT, Boland LL, Burke MN, Kebed KY, Graham KJ, Henry TD, Katsiyiannis WT, Satterlee PA, Sendelbach S, Hodges JS, Parham WM. Therapeutic hypothermia after out-of-hospital cardiac arrest: evaluation of a regional system to increase access to cooling. Circulation. 2011 Jul 12;124(2):206-14. doi: 10.1161/CIRCULATIONAHA.110.986257.

    PMID: 21747066BACKGROUND
  • Komatsu T, Kinoshita K, Sakurai A, Moriya T, Yamaguchi J, Sugita A, Kogawa R, Tanjoh K. Shorter time until return of spontaneous circulation is the only independent factor for a good neurological outcome in patients with postcardiac arrest syndrome. Emerg Med J. 2014 Jul;31(7):549-555. doi: 10.1136/emermed-2013-202457. Epub 2013 May 2.

    PMID: 23639589BACKGROUND
  • Saravanan P, Davidson NC. Risk assessment for sudden cardiac death in dialysis patients. Circ Arrhythm Electrophysiol. 2010 Oct;3(5):553-9. doi: 10.1161/CIRCEP.110.937888. No abstract available.

    PMID: 20959609BACKGROUND
  • Surana SP, Pun PH, Keithi-Reddy SR, Spiegel SM, Middleton JP, Singh AK. Sudden cardiac arrest in ESRD patients. Clin Nephrol. 2014 Feb;81(2):121-31. doi: 10.5414/CN107667.

    PMID: 23149247BACKGROUND
  • Hasselqvist-Ax I, Riva G, Herlitz J, Rosenqvist M, Hollenberg J, Nordberg P, Ringh M, Jonsson M, Axelsson C, Lindqvist J, Karlsson T, Svensson L. Early cardiopulmonary resuscitation in out-of-hospital cardiac arrest. N Engl J Med. 2015 Jun 11;372(24):2307-15. doi: 10.1056/NEJMoa1405796.

    PMID: 26061835BACKGROUND
  • Seder DB, Patel N, McPherson J, McMullan P, Kern KB, Unger B, Nanda S, Hacobian M, Kelley MB, Nielsen N, Dziodzio J, Mooney M; International Cardiac Arrest Registry (INTCAR)-Cardiology Research Group. Geriatric experience following cardiac arrest at six interventional cardiology centers in the United States 2006-2011: interplay of age, do-not-resuscitate order, and outcomes. Crit Care Med. 2014 Feb;42(2):289-95. doi: 10.1097/CCM.0b013e3182a26ec6.

    PMID: 24107639BACKGROUND
  • Larkin GL, Copes WS, Nathanson BH, Kaye W. Pre-resuscitation factors associated with mortality in 49,130 cases of in-hospital cardiac arrest: a report from the National Registry for Cardiopulmonary Resuscitation. Resuscitation. 2010 Mar;81(3):302-11. doi: 10.1016/j.resuscitation.2009.11.021. Epub 2010 Jan 4.

    PMID: 20047786BACKGROUND
  • Hollenbeck RD, McPherson JA, Mooney MR, Unger BT, Patel NC, McMullan PW Jr, Hsu CH, Seder DB, Kern KB. Early cardiac catheterization is associated with improved survival in comatose survivors of cardiac arrest without STEMI. Resuscitation. 2014 Jan;85(1):88-95. doi: 10.1016/j.resuscitation.2013.07.027. Epub 2013 Aug 6.

    PMID: 23927955BACKGROUND
  • Kern KB, Lotun K, Patel N, Mooney MR, Hollenbeck RD, McPherson JA, McMullan PW, Unger B, Hsu CH, Seder DB; INTCAR-Cardiology Registry. Outcomes of Comatose Cardiac Arrest Survivors With and Without ST-Segment Elevation Myocardial Infarction: Importance of Coronary Angiography. JACC Cardiovasc Interv. 2015 Jul;8(8):1031-1040. doi: 10.1016/j.jcin.2015.02.021. Epub 2015 Jun 24.

    PMID: 26117462BACKGROUND
  • Callaway CW, Schmicker RH, Brown SP, Albrich JM, Andrusiek DL, Aufderheide TP, Christenson J, Daya MR, Falconer D, Husa RD, Idris AH, Ornato JP, Rac VE, Rea TD, Rittenberger JC, Sears G, Stiell IG; ROC Investigators. Early coronary angiography and induced hypothermia are associated with survival and functional recovery after out-of-hospital cardiac arrest. Resuscitation. 2014 May;85(5):657-63. doi: 10.1016/j.resuscitation.2013.12.028. Epub 2014 Jan 8.

    PMID: 24412161BACKGROUND
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    PMID: 20484098BACKGROUND
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    PMID: 20956217BACKGROUND
  • Rab T, Kern KB, Tamis-Holland JE, Henry TD, McDaniel M, Dickert NW, Cigarroa JE, Keadey M, Ramee S; Interventional Council, American College of Cardiology. Cardiac Arrest: A Treatment Algorithm for Emergent Invasive Cardiac Procedures in the Resuscitated Comatose Patient. J Am Coll Cardiol. 2015 Jul 7;66(1):62-73. doi: 10.1016/j.jacc.2015.05.009.

    PMID: 26139060BACKGROUND
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    PMID: 4136544BACKGROUND
  • Schefold JC, Storm C, Kruger A, Ploner CJ, Hasper D. The Glasgow Coma Score is a predictor of good outcome in cardiac arrest patients treated with therapeutic hypothermia. Resuscitation. 2009 Jun;80(6):658-61. doi: 10.1016/j.resuscitation.2009.03.006. Epub 2009 Apr 11.

    PMID: 19362767BACKGROUND
  • Passamani ER, Weisfeldt ML. 31st Bethesda Conference. Emergency Cardiac Care. Task force 3: Special aspects of research conduct in the emergency setting: Waiver of informed consent. J Am Coll Cardiol. 2000 Mar 15;35(4):862-80. No abstract available.

    PMID: 10732882BACKGROUND
  • Brennan JM, Curtis JP, Dai D, Fitzgerald S, Khandelwal AK, Spertus JA, Rao SV, Singh M, Shaw RE, Ho KK, Krone RJ, Weintraub WS, Weaver WD, Peterson ED; National Cardiovascular Data Registry. Enhanced mortality risk prediction with a focus on high-risk percutaneous coronary intervention: results from 1,208,137 procedures in the NCDR (National Cardiovascular Data Registry). JACC Cardiovasc Interv. 2013 Aug;6(8):790-9. doi: 10.1016/j.jcin.2013.03.020.

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    PMID: 46957BACKGROUND
  • Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.

    PMID: 11856793BACKGROUND
  • Cummins RO, Ornato JP, Thies WH, Pepe PE. Improving survival from sudden cardiac arrest: the "chain of survival" concept. A statement for health professionals from the Advanced Cardiac Life Support Subcommittee and the Emergency Cardiac Care Committee, American Heart Association. Circulation. 1991 May;83(5):1832-47. doi: 10.1161/01.cir.83.5.1832. No abstract available.

    PMID: 2022039BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Michael E Mollerus, MD

    Essentia Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 14, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

May 20, 2020

Record last verified: 2020-05

Locations