The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest

Sudden Cardiac Death Clinical Trial

— EPS ARREST  

Official title:

The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03079414
• Other study ID #: 108939
• Status: Recruiting
• Start date: May 1, 2017
• Est. completion date: May 31, 2023

Study information

• Verified date: April 2022
• Source: Western University, Canada
• Contact: Jason D Roberts, MD MAS
• Phone: (519) 663-3746
• Email: jason.roberts[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Heart Arrest
• Sudden Cardiac Death

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Laval University	Quebec City	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
Canada	University of British Columbia	Vancouver	British Columbia
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Inova Heart and Vascular Institute	Falls Church	Virginia
United States	Queen's Medical Center	Honolulu	Hawaii
United States	UCLA Medical Center	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Oregon Health & Science University	Portland	Oregon
United States	Regions Hospital	Saint Paul	Minnesota
United States	University of Utah	Salt Lake City	Utah
United States	UC San Diego Health System	San Diego	California
United States	UCSF Medical Center	San Francisco	California
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

United States,  Canada,  Israel, 

References & Publications (3)

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. Erratum in: Circulation. 2010 Jun 29;121(25):e460. — View Citation

Roberts JD, Gollob MH, Young C, Connors SP, Gray C, Wilton SB, Green MS, Zhu DW, Hodgkinson KA, Poon A, Li Q, Orr N, Tang AS, Klein GJ, Wojciak J, Campagna J, Olgin JE, Badhwar N, Vedantham V, Marcus GM, Kwok PY, Deo RC, Scheinman MM. Bundle Branch Re-Entrant Ventricular Tachycardia: Novel Genetic Mechanisms in a Life-Threatening Arrhythmia. JACC Clin Electrophysiol. 2017 Mar;3(3):276-288. doi: 10.1016/j.jacep.2016.09.019. Epub 2016 Dec 21. — View Citation

Wang YS, Scheinman MM, Chien WW, Cohen TJ, Lesh MD, Griffin JC. Patients with supraventricular tachycardia presenting with aborted sudden death: incidence, mechanism and long-term follow-up. J Am Coll Cardiol. 1991 Dec;18(7):1711-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrhythmic culprit for aborted cardiac arrest	Identification of an arrhythmic culprit for aborted cardiac arrest using an invasive electrophysiology study.	Assessed immediately upon testing
Secondary	Prevalence of bundle branch reentrant ventricular tachycardia	Prevalence of bundle branch reentrant ventricular tachycardia among survivors of unexplained cardiac arrest.	Assessed immediately upon testing
Secondary	Prevalence of supraventricular tachycardia associated with hemodynamic collapse	Prevalence of inducible supraventricular tachycardia during invasive electrophysiology study among survivors of unexplained cardiac arrest.	Assessed immediately upon testing
Secondary	Prevalence of a latent/cryptic accessory pathway	Prevalence of a latent/cryptic accessory pathway among survivors of unexplained cardiac arrest.	Assessed immediately upon testing.