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| Sponsored by: |
CardioDx |
| Information provided by: | CardioDx |
| ClinicalTrials.gov Identifier: | NCT00583297 |
Purpose
The ABCD clinical study (ClinicalTrials.gov 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.
| Condition | Intervention |
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Coronary Artery Disease Heart Failure Ventricular Tachycardia |
Other: Blood Draw |
| Genetics Home Reference related topics: | Brugada syndrome short QT syndrome |
| MedlinePlus related topics: | Arrhythmia Coronary Artery Disease Heart Diseases Heart Failure |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Identifying Genetic Markers That Predict Microvolt T-Wave Alternans Status and Arrhythmia Risk in Patients With Ischemic Heart Disease |
Whole blood and saliva.
| Estimated Enrollment: | 400 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
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ABCD Subjects
The cohort will consist of original subjects of the ABCD trial who consent to participate in the genetic sub-study
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Other: Blood Draw
No Intervention.
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The target population for the ABCD genetic sub-study includes all living individuals currently enrolled in the ABCD trial (total study enrollment=629; 566 analyzed in the trial) Participants of the ABCD trial underwent TWA and EPS testing to determine their risk for ventricular arrhythmia and most have received an implantable cardioverter defibrillator (ICD). The ABCD trial collected extensive longitudinal clinical data including medical and medication histories, incidence of ventricular arrhythmias, defibrillator shocks, other cardiovascular events, and mortality.
Inclusion Criteria:
Subjects previously enrolled in the ABCD trial sponsored by St. Jude Medical (ClinicalTrials.gov Identifier NCT00187291)
Exclusion Criteria:
Individuals who were not previously enrolled in the ABCD trial are not eligible for this genetic sub-study.
Contacts and Locations| Contact: Elizabeth Kaufman, MD | (216) 778-2349 | ekaufman@metrohealth.org |
| Contact: Mary Dettmer, RN, BSN | (216) 778-2223 | mdettmer@metrohealth.org |
| United States, Ohio | |||||
| MetroHealth Medical Center | Recruiting | ||||
| Cleveland, Ohio, United States, 44109 | |||||
| Principal Investigator: Elizabeth Kaufman, MD | |||||
| Sub-Investigator: David Rosenbaum, MD | |||||
| CardioDx |
| Study Director: | Amy J Sehnert, MD | CardioDx, Inc. |
| Principal Investigator: | Elizabeth Kaufman, MD | MetroHealth Medical Center |
More Information
| Responsible Party: | CardioDx, Inc. ( Amy Sehnert, MD, Director, Clinical R&D ) |
| Study ID Numbers: | CDx_000001 |
| First Received: | December 20, 2007 |
| Last Updated: | December 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00583297 |
| Health Authority: | United States: Institutional Review Board |
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