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

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ClinicalTrials.gov Identifier: NCT03079414
Recruitment Status : Recruiting
First Posted : March 14, 2017
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
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.


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

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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03079414


Contacts
Contact: Jason D Roberts, MD MAS (519) 663-3746 ext 34526 jason.roberts@lhsc.on.ca

Locations
United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Jason S Bradfield, MD         
UC San Diego Health System Not yet recruiting
San Diego, California, United States, 92037
Contact: Kurt S Hoffmayer, MD PharmD         
Contact: Jonathan C Hsu, MD MAS         
UCSF Medical Center Recruiting
San Francisco, California, United States, 94143-0124
Contact: Melvin M Scheinman, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Marco V Perez, MD         
United States, Colorado
University of Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Duy T Nguyen, MD         
United States, Hawaii
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: David K Singh, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Steven A Lubitz, MD MPH         
United States, Minnesota
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Dennis W Zhu, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Babak Nazer, MD         
Contact: Thomas A Dewland, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Benjamin Shoemaker, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Ravi Ranjan, MD         
United States, Virginia
Inova Heart and Vascular Institute Not yet recruiting
Falls Church, Virginia, United States, 22042
Contact: Leonard Ilkhanoff, MD         
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Shubhayan Sanatani, MD         
University of British Columbia Recruiting
Vancouver, British Columbia, Canada
Contact: Andrew D Krahn, MD         
Contact: Zachary Laksman, MD         
Canada, Nova Scotia
QEII Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada
Contact: Martin Gardner, MD         
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada
Contact: Jeff Healey, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Jason D Roberts, MD MAS         
Toronto General Hospital Recruiting
Toronto, Ontario, Canada
Contact: Michael H Gollob, MD         
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada
Contact: Rafik Tadros, MD PhD         
Laval University Recruiting
Quebec City, Quebec, Canada
Contact: Christian Steinberg, MD         
Israel
Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel
Contact: Raphael Rosso, MD         
Contact: Sami Viskin, MD         
Sponsors and Collaborators
Western University, Canada
Canadian Institutes of Health Research (CIHR)
Investigators
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

Publications:
Responsible Party: Western University, Canada
ClinicalTrials.gov Identifier: NCT03079414     History of Changes
Other Study ID Numbers: 108939
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no current plan to share IPD with other researchers.

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
Genetics

Additional relevant MeSH terms:
Heart Arrest
Death
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Death, Sudden