Ignite Creation Date:
2024-05-05 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00583297
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2007-12-20
Brief Title:
Genetic Substudy of the Alternans Before Cardioverter Defibrillator ABCD Trial
Sponsor:
CardioDx
Organization:
CardioDx
Study Overview
Official Title:
Identifying Genetic Markers That Predict Microvolt T-wave Alternans Status and Arrhythmia Risk in Patients With Ischemic Heart Disease
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABCD
Brief Summary:
The ABCD clinical study ClinicalTrialsgov Identifier NCT00187291 was designed to determine if a T-Wave Alternans TWA test is equivalent to an Electrophysiology Study EPS in predicting life-threatening heart rhythms in patients with ischemic heart disease left ventricular dysfunction and non-sustained tachycardia The purpose of the ABCD Genetic sub-study is to identify genetic markers that predict TWA status and arrhythmia risk in this same population
Detailed Description:
The primary objective of this study is to test the hypothesis that therapy directed primarily by a T wave alternans TWA test measured non-invasively during exercise is equivalent to therapy directed by an electrophysiological study EPS in predicting spontaneous ventricular tachyarrhythmic events VTEs in patients with ischemic heart disease left ventricular dysfunction and asymptomatic non-sustained ventricular tachycardia NSVT In the absence of any previous life-threatening ventricular arrhythmia ie for primary prevention ICD implantation is currently indicated in patients with ischemic heart disease left ventricular dysfunction asymptomatic non-sustained ventricular tachycardia and a positive EPS The objective of this study is to demonstrate that a TWA test directed therapy is equivalent to EPS directed therapy in guiding ICD implantation for the purpose of primary prevention of sudden cardiac death SCD in patients with ischemic heart disease left ventricular dysfunction and asymptomatic non-sustained ventricular tachycardia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ABCD | OTHER | CardioDx | None |