Registry of Unexplained Cardiac Arrest

NCT00292032 | Completed DMC

• 2 other identifiers: R-04-09910076
• Study Type: observational
• Target: 1,529
• Locations: 1 country
• Sites: 1

Brief Summary

The CASPER will collect systematic clinical assessments of patients and families within the multicenter Canadian Inherited Heart Rhythm Research Network. Unexplained Cardiac Arrest patients and family members will undergo standardized testing for evidence of primary electrical disease and latent cardiomyopathy along with clinical genetics screening of affected individuals based on an evident or unmasked phenotype.

Conditions

Cardiac Arrest; Long QT Syndrome; Brugada Syndrome; Catecholaminergi Polymorphic Ventricular Tachycardia; Idiopathic VentricularFibrillation; Early Repolarization Syndrome; Arrhythmogenic Right Ventricular Cardiomyopathy

Keywords

cardiac arrest; diagnosis; genetics; testing

Outcome Measures

Primary Outcomes (1)

• Developing and Testing Algorithms for Diagnostics and Treatments in Survivors of Unexplained Cardiac Arrest

  Long Term follow up data on survivors of cardiac arrest Long term monitoring of high risk patients and familymembers with an Injectable Cardiac Monitor 24 hour holter monitoring during provocative testing with epinephrine infusion and ambulatory activities to detect subclinical repolarization

  25 years

Study Arms (2)

Cardiac Arrest Survivors or Post Mortem Unexplained Cardiac

Probands - Unexplained Cardiac Arrest Survivors and Post Mortem Unexplained Cardiac Arrest Cases

First Degree Family Members

First Degree Family Members of those affected by Sudden Unexplained Cardiac Arrest

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unexplained cardiac arrest patients, and first degree relatives of 1) UCA patients 2) patients with known primary electrical disease or 3) unexplained sudden death before age 60

You may qualify if:

• Cardiac arrest requiring cardioversion or defibrillation.
• Syncope with documented polymorphic ventricular tachycardia felt to be responsible for the index event.
• First degree relative of an index case of UCA undergoing clinical testing.
• First degree relative of a family member with UCA or sudden death before age 35 with a negative autopsy for cause of death, presumed arrhythmic.
• First degree relative of a family member with UCA or sudden death with objective evidence of primary electrical disease, such as a diagnostic electrocardiogram (ECG), exercise test, drug infusion, or genetic testing.

You may not qualify if:

• Coronary artery disease (stenosis \> 50%)
• Reduced left ventricular function (left ventricular ejection fraction \[LVEF\] \< 50%)
• Event managed without an implantable cardioverter defibrillator \[ICD\] (for follow-up portion)
• Unwilling or unable to provide clinical follow-up (for follow-up portion)
• Comorbidity making survival of \> 1 year unlikely
• Persistent resting QTc \> 460 msec for males and 480 msec for females
• Reversible cause of cardiac arrest such as marked hypokalemia (\< 2.8 mmol/l) or drug overdose sufficient in gravity without other cause to explain the cardiac arrest
• Hemodynamically stable sustained monomorphic ventricular tachycardia with a QRS morphology consistent with recognized forms of idiopathic ventricular tachycardia (outflow tract or apical septal)
• Brugada's sign with e2 mm ST elevation in V1 and/or V2
• Unwilling or unable to provide consent

Sponsors & Collaborators

• Kingston Health Sciences Centre: collaborator
• University of British Columbia: lead
• Quebec Heart Institute: collaborator
• The Queen Elizabeth Hospital: collaborator
• St. Boniface Hospital: collaborator
• Unity Health Toronto: collaborator
• Vancouver Island Health Authority: collaborator
• Provincial Health Services Authority British Columbia: collaborator
• Montreal Heart Institute: collaborator
• Ottawa Heart Institute Research Corporation: collaborator
• University of Calgary: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6E 1M7, Canada

Location

Related Publications (10)

• Krahn AD, Gollob M, Yee R, Gula LJ, Skanes AC, Walker BD, Klein GJ. Diagnosis of unexplained cardiac arrest: role of adrenaline and procainamide infusion. Circulation. 2005 Oct 11;112(15):2228-34. doi: 10.1161/CIRCULATIONAHA.105.552166. Epub 2005 Oct 3.

  PMID: 16203906 RESULT

• Krahn AD, Healey JS, Chauhan V, Birnie DH, Simpson CS, Champagne J, Gardner M, Sanatani S, Exner DV, Klein GJ, Yee R, Skanes AC, Gula LJ, Gollob MH. Systematic assessment of patients with unexplained cardiac arrest: Cardiac Arrest Survivors With Preserved Ejection Fraction Registry (CASPER). Circulation. 2009 Jul 28;120(4):278-85. doi: 10.1161/CIRCULATIONAHA.109.853143. Epub 2009 Jul 13.

  PMID: 19597050 RESULT

• Davies B, Bartels K, Hathaway J, Xu F, Roberts JD, Tadros R, Green MS, Healey JS, Simpson CS, Sanatani S, Steinberg C, Gardner M, Angaran P, Talajic M, Hamilton R, Arbour L, Seifer C, Fournier A, Joza J, Krahn AD, Lehman A, Laksman ZWM. Variant Reinterpretation in Survivors of Cardiac Arrest With Preserved Ejection Fraction (the Cardiac Arrest Survivors With Preserved Ejection Fraction Registry) by Clinicians and Clinical Commercial Laboratories. Circ Genom Precis Med. 2021 Jun;14(3):e003235. doi: 10.1161/CIRCGEN.120.003235. Epub 2021 May 7.

  PMID: 33960826 DERIVED

• Cheung CC, Davies B, Gibbs K, Laksman ZW, Krahn AD. Patch monitors for arrhythmia monitoring in patients for suspected inherited arrhythmia syndrome. J Cardiovasc Electrophysiol. 2021 Mar;32(3):856-859. doi: 10.1111/jce.14917. Epub 2021 Feb 15.

  PMID: 33512057 DERIVED

• Mellor G, Laksman ZWM, Tadros R, Roberts JD, Gerull B, Simpson CS, Klein GJ, Champagne J, Talajic M, Gardner M, Steinberg C, Arbour L, Birnie DH, Angaran P, Leather R, Sanatani S, Chauhan VS, Seifer C, Healey JS, Krahn AD. Genetic Testing in the Evaluation of Unexplained Cardiac Arrest: From the CASPER (Cardiac Arrest Survivors With Preserved Ejection Fraction Registry). Circ Cardiovasc Genet. 2017 Jun;10(3):e001686. doi: 10.1161/CIRCGENETICS.116.001686.

  PMID: 28600387 DERIVED

• Steinberg C, Padfield GJ, Champagne J, Sanatani S, Angaran P, Andrade JG, Roberts JD, Healey JS, Chauhan VS, Birnie DH, Janzen M, Gerull B, Klein GJ, Leather R, Simpson CS, Seifer C, Talajic M, Gardner M, Krahn AD. Cardiac Abnormalities in First-Degree Relatives of Unexplained Cardiac Arrest Victims: A Report From the Cardiac Arrest Survivors With Preserved Ejection Fraction Registry. Circ Arrhythm Electrophysiol. 2016 Sep;9(9):e004274. doi: 10.1161/CIRCEP.115.004274.

  PMID: 27635072 DERIVED

• Herman AR, Cheung C, Gerull B, Simpson CS, Birnie DH, Klein GJ, Champagne J, Healey JS, Gibbs K, Talajic M, Gardner M, Bennett MT, Steinberg C, Janzen M, Gollob MH, Angaran P, Yee R, Leather R, Chakrabarti S, Sanatani S, Chauhan VS, Krahn AD. Outcome of Apparently Unexplained Cardiac Arrest: Results From Investigation and Follow-Up of the Prospective Cardiac Arrest Survivors With Preserved Ejection Fraction Registry. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003619. doi: 10.1161/CIRCEP.115.003619.

  PMID: 26783233 DERIVED

• Krahn AD, Healey JS, Chauhan VS, Birnie DH, Champagne J, Sanatani S, Ahmad K, Ballantyne E, Gerull B, Yee R, Skanes AC, Gula LJ, Leong-Sit P, Klein GJ, Gollob MH, Simpson CS, Talajic M, Gardner M. Epinephrine infusion in the evaluation of unexplained cardiac arrest and familial sudden death: from the cardiac arrest survivors with preserved Ejection Fraction Registry. Circ Arrhythm Electrophysiol. 2012 Oct;5(5):933-40. doi: 10.1161/CIRCEP.112.973230. Epub 2012 Sep 3.

  PMID: 22944906 DERIVED

• Krahn AD, Healey JS, Simpson CS, Chauhan VS, Birnie DH, Champagne J, Gardner M, Sanatani S, Chakrabarti S, Yee R, Skanes AC, Leong-Sit P, Ahmad K, Gollob MH, Klein GJ, Gula LJ, Sheldon RS. Sentinel symptoms in patients with unexplained cardiac arrest: from the cardiac arrest survivors with preserved ejection fraction registry (CASPER). J Cardiovasc Electrophysiol. 2012 Jan;23(1):60-6. doi: 10.1111/j.1540-8167.2011.02185.x. Epub 2011 Sep 28.

  PMID: 21955300 DERIVED

• Derval N, Simpson CS, Birnie DH, Healey JS, Chauhan V, Champagne J, Gardner M, Sanatani S, Yee R, Skanes AC, Gula LJ, Leong-Sit P, Ahmad K, Gollob MH, Haissaguerre M, Klein GJ, Krahn AD. Prevalence and characteristics of early repolarization in the CASPER registry: cardiac arrest survivors with preserved ejection fraction registry. J Am Coll Cardiol. 2011 Aug 9;58(7):722-8. doi: 10.1016/j.jacc.2011.04.022.

  PMID: 21816308 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Heart Arrest; Long QT Syndrome; Brugada Syndrome; Arrhythmogenic Right Ventricular Dysplasia; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genetic Diseases, Inborn; Cardiomyopathies

Study Officials

• Andrew D Krahn, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Iinvestigator

Study Record Dates

• First Submitted: February 14, 2006
• First Posted: February 15, 2006
• Study Start: May 1, 2004
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)