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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03079414 |
|
Recruitment Status : Unknown
Verified April 2022 by Western University, Canada.
Recruitment status was: Recruiting
First Posted : March 14, 2017
Last Update Posted : May 3, 2022
|
Sponsor:
Western University, Canada
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Western University, Canada
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | March 2, 2017 | |||||||||
| First Posted Date | March 14, 2017 | |||||||||
| Last Update Posted Date | May 3, 2022 | |||||||||
| Actual Study Start Date | May 1, 2017 | |||||||||
| Estimated Primary Completion Date | March 30, 2023 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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.
|
|||||||||
| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
|
|||||||||
| Original Secondary Outcome Measures |
|
|||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest | |||||||||
| Official Title | The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest | |||||||||
| 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. | |||||||||
| 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 | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
|||||||||
| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Retention: Samples With DNA Description: DNA will attempted to be collected for all patients.
|
|||||||||
| 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. | |||||||||
| Condition | 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.
|
|||||||||
| Study Groups/Cohorts | Unexplained Aborted Cardiac Arrest
Survivors of sudden cardiac death with no identifiable etiology following initial diagnostic workup.
Intervention: Procedure: Invasive Electrophysiology Study
|
|||||||||
| Publications * |
|
|||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status | Unknown status | |||||||||
| Estimated Enrollment |
100 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | May 31, 2023 | |||||||||
| Estimated Primary Completion Date | March 30, 2023 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||
| Sex/Gender |
|
|||||||||
| Ages | Child, Adult, Older Adult | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Canada, Israel, United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT03079414 | |||||||||
| Other Study ID Numbers | 108939 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
|
|||||||||
| IPD Sharing Statement |
|
|||||||||
| Current Responsible Party | Western University, Canada | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor | Western University, Canada | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators | Canadian Institutes of Health Research (CIHR) | |||||||||
| Investigators |
|
|||||||||
| PRS Account | Western University, Canada | |||||||||
| Verification Date | April 2022 | |||||||||