Risk Stratification of Patients Presenting With Cardiac Arrest
1 other identifier
observational
100
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2016
Longer than P75 for all trials
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
April 11, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedMay 20, 2020
May 1, 2020
4.1 years
April 11, 2016
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
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
- Essentia Healthlead
Study Sites (1)
St. Mary's MedicalCenter
Duluth, Minnesota, 55811, United States
Related Publications (25)
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PMID: 6709008BACKGROUNDLloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Stafford R, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):948-54. doi: 10.1161/CIRCULATIONAHA.109.192666. No abstract available.
PMID: 20177011BACKGROUNDIdris AH, Guffey D, Aufderheide TP, Brown S, Morrison LJ, Nichols P, Powell J, Daya M, Bigham BL, Atkins DL, Berg R, Davis D, Stiell I, Sopko G, Nichol G; Resuscitation Outcomes Consortium (ROC) Investigators. Relationship between chest compression rates and outcomes from cardiac arrest. Circulation. 2012 Jun 19;125(24):3004-12. doi: 10.1161/CIRCULATIONAHA.111.059535. Epub 2012 May 23.
PMID: 22623717BACKGROUNDSpaite DW, Bobrow BJ, Stolz U, Berg RA, Sanders AB, Kern KB, Chikani V, Humble W, Mullins T, Stapczynski JS, Ewy GA; Arizona Cardiac Receiving Center Consortium. Statewide regionalization of postarrest care for out-of-hospital cardiac arrest: association with survival and neurologic outcome. Ann Emerg Med. 2014 Nov;64(5):496-506.e1. doi: 10.1016/j.annemergmed.2014.05.028. Epub 2014 Jul 23.
PMID: 25064741BACKGROUNDMooney 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: 21747066BACKGROUNDKomatsu 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: 23639589BACKGROUNDSaravanan 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: 20959609BACKGROUNDSurana 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: 23149247BACKGROUNDHasselqvist-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: 26061835BACKGROUNDSeder 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: 24107639BACKGROUNDLarkin 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: 20047786BACKGROUNDHollenbeck 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: 23927955BACKGROUNDKern 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: 26117462BACKGROUNDCallaway 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: 24412161BACKGROUNDDumas F, Cariou A, Manzo-Silberman S, Grimaldi D, Vivien B, Rosencher J, Empana JP, Carli P, Mira JP, Jouven X, Spaulding C. Immediate percutaneous coronary intervention is associated with better survival after out-of-hospital cardiac arrest: insights from the PROCAT (Parisian Region Out of hospital Cardiac ArresT) registry. Circ Cardiovasc Interv. 2010 Jun 1;3(3):200-7. doi: 10.1161/CIRCINTERVENTIONS.109.913665. Epub 2010 May 18.
PMID: 20484098BACKGROUNDField JM, Hazinski MF, Sayre MR, Chameides L, Schexnayder SM, Hemphill R, Samson RA, Kattwinkel J, Berg RA, Bhanji F, Cave DM, Jauch EC, Kudenchuk PJ, Neumar RW, Peberdy MA, Perlman JM, Sinz E, Travers AH, Berg MD, Billi JE, Eigel B, Hickey RW, Kleinman ME, Link MS, Morrison LJ, O'Connor RE, Shuster M, Callaway CW, Cucchiara B, Ferguson JD, Rea TD, Vanden Hoek TL. Part 1: executive summary: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S640-56. doi: 10.1161/CIRCULATIONAHA.110.970889.
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PMID: 26139060BACKGROUNDTeasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974 Jul 13;2(7872):81-4. doi: 10.1016/s0140-6736(74)91639-0. No abstract available.
PMID: 4136544BACKGROUNDSchefold 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: 19362767BACKGROUNDPassamani 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: 10732882BACKGROUNDBrennan 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: 46957BACKGROUNDHypothermia 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: 11856793BACKGROUNDCummins 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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael E Mollerus, MD
Essentia Health
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