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The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest (EPS ARREST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03079414
Recruitment Status : Recruiting
First Posted : March 14, 2017
Last Update Posted : September 23, 2019
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Western University, Canada

Brief Summary:
Sudden cardiac death (SCD) remains a major cause of mortality within developed nations despite aggressive efforts to reduce its societal burden. Despite extensive clinical and genetic investigations, a subgroup of cardiac arrests remain unexplained, highlighting the potential contribution of additional cardiac conditions that may not be identified with contemporary diagnostic algorithms. The EPS ARREST study aims to evaluate the role of invasive electrophysiology study within this patient population.

Condition or disease Intervention/treatment
Sudden Cardiac Death Procedure: Invasive Electrophysiology Study

Detailed Description:

The majority of cases of SCD in older individuals occur secondary to coronary and structural heart disease, while genetic channelopathies and cardiomyopathies are prominent contributors in young adults. Among individuals that suffer aborted cardiac arrests in the absence of overt coronary and structural heart disease, diagnostic algorithms that screen for cardiac channelopathies and more subtle forms of structural heart disease have been established. Despite the extensive investigations currently utilized, a significant proportion of aborted cardiac arrests remain unexplained.

Although invasive electrophysiology studies are a cornerstone for diagnosis and management of arrhythmia disorders, they are not invariably included in the workup of cases of unexplained aborted cardiac arrest. This is largely driven by initial studies suggesting that the diagnostic yield in this context is low, however these investigations often used invasive electrophysiology studies indiscriminately in all cases of aborted cardiac arrest. Since these earlier studies, our insight and approach to SCD has evolved and it has become clear that the majority of patients do not require an invasive electrophysiology study for diagnosis. However an invasive electrophysiology study may still have an important role among these individuals when the initial workup is negative. Notably, arrhythmias that require invasive electrophysiology for diagnosis, including bundle branch reentrant ventricular tachycardia and supraventricular tachycardias associated with hemodynamic collapse, have been identified as arrhythmic culprits in this patient population.

The goal of the EPS ARREST study is to evaluate the diagnostic yield of a standardized invasive electrophysiology study among survivors of SCD when initial investigations fail to identify an underlying etiology.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Group/Cohort Intervention/treatment
Unexplained Aborted Cardiac Arrest
Survivors of sudden cardiac death with no identifiable etiology following initial diagnostic workup.
Procedure: Invasive Electrophysiology Study
Invasive electrophysiology studies will be performed using four catheters placed in the right ventricular apex, the coronary sinus, the His bundle region, and the high right atrium. Standard induction protocols for supraventricular and ventricular arrhythmias will be utilized in the absence and presence of isoproterenol. Long-short ventricular extra-stimuli will also be delivered to screen for bundle branch reentrant ventricular tachycardia. The study is considered observational as the participating sites perform electrophysiology studies in this patient population as part of standard clinical care.

Primary Outcome Measures :
  1. Arrhythmic culprit for aborted cardiac arrest [ Time Frame: Assessed immediately upon testing ]
    Identification of an arrhythmic culprit for aborted cardiac arrest using an invasive electrophysiology study.

Secondary Outcome Measures :
  1. Prevalence of bundle branch reentrant ventricular tachycardia [ Time Frame: Assessed immediately upon testing ]
    Prevalence of bundle branch reentrant ventricular tachycardia among survivors of unexplained cardiac arrest.

  2. Prevalence of supraventricular tachycardia associated with hemodynamic collapse [ Time Frame: Assessed immediately upon testing ]
    Prevalence of inducible supraventricular tachycardia during invasive electrophysiology study among survivors of unexplained cardiac arrest.

  3. Prevalence of a latent/cryptic accessory pathway [ Time Frame: Assessed immediately upon testing. ]
    Prevalence of a latent/cryptic accessory pathway among survivors of unexplained cardiac arrest.

Biospecimen Retention:   Samples With DNA
DNA will attempted to be collected for all patients.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Survivors of unexplained sudden cardiac death for whom an underlying etiology remains unclear following a standard diagnostic workup, including 12-lead surface ECG, coronary artery assessment, echocardiography, cardiac MRI with late gadolinium enhancement, procainamide challenge, and exercise treadmill testing.

Inclusion Criteria:

  1. Unexplained cardiac arrest requiring cardioversion or defibrillation
  2. Willing and able to sign informed consent

Exclusion Criteria:

  1. Coronary artery disease (stenosis > 50%) and clinical findings consistent with an ischemic arrest
  2. Reduced left ventricular function (left ventricular ejection fraction < 50%) on echocardiogram or cardiac MRI.
  3. Persistent resting QTc > 460 msec for males and 480 msec for females
  4. Resting QTc < 350 msec
  5. Type I Brugada ECG with >/= 2 mm ST elevation in V1 and/or V2 (Spontaneous or Drug-Induced)
  6. Polymorphic or bidirectional ventricular tachycardia observed with exertion on exercise treadmill testing
  7. Clinical, electrocardiographic, and/or imaging findings consistent with a diagnosis of arrhythmogenic right ventricular cardiomyopathy
  8. Myocarditis
  9. Reversible cause of cardiac arrest such as marked hypokalemia (<2.8 mmol/l) or drug overdose sufficient in severity without other cause to explain the cardiac arrest.
  10. Arrhythmic mitral valve prolapse syndrome
  11. Documented ventricular fibrillation initiated by a short-coupled premature ventricular contraction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03079414

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Contact: Jason D Roberts, MD MAS (519) 663-3746 ext 34526

Show Show 21 study locations
Sponsors and Collaborators
Western University, Canada
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: Jason D Roberts, MD MAS Western University
Study Director: Andrew D Krahn, MD University of British Columbia
Study Director: Melvin M Scheinman, MD University of California, San Francisco
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Responsible Party: Western University, Canada Identifier: NCT03079414    
Other Study ID Numbers: 108939
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no current plan to share IPD with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Western University, Canada:
Sudden Cardiac Death
Cardiac Arrhythmia
Electrophysiology Study
Additional relevant MeSH terms:
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Heart Arrest
Death, Sudden, Cardiac
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Death, Sudden