Diagnostic Investigation of Sudden Cardiac Event Risk



Status:Completed
Conditions:Angina, Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 90
Updated:10/21/2017
Start Date:July 2007
End Date:August 1, 2011

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Identifying Markers That Predict Ventricular Arrhythmia Risk

The overall objective of the DISCERN study is to develop and validate a genomic diagnostic
assay to identify patients at increased risk for lethal ventricular arrhythmias and sudden
cardiac death (SCD).

This is a prospective, multi-center, observational study. The research will be performed in
three phases, each using distinct patient cohorts:

Phase I: Discovery - genes/biomarkers/clinical factors Phase II: Algorithm Development Phase
III: Assay Validation

The final algorithm (Assay) may incorporate a combination of factors including genetic
markers, biomarker(s), and clinical factor(s). Participation in the study does not alter
clinical care. The procedures required by the protocol are collection of a research blood
sample (at baseline only) and interviews with the subject to collect specific clinical
information at baseline and follow-up (6 mos, 1 yr, 2 yr, 3 yr, 4 yr, and 5 yr) after
enrollment. All other data collected is in accordance with the participating institution's
standard patient care.

Inclusion Criteria:

- Implantable cardiac defibrilIator (ICD) or cardiac resynchronization therapy
defibrillator (CRT-D) implanted for primary prevention

- Left ventricular ejection fraction (LVEF) ≤ 50 %

- Ability to collect clinical follow-up and endpoint information, including device
interrogation data

Exclusion Criteria:

- Congenital heart disease

- Known inherited arrhythmia disorder

- Organ transplantation

- Inability to give informed consent
We found this trial at
8
sites
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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Anchorage, Alaska 99508
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Anchorage, AK
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Minneapolis, Minnesota 55407
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Minneapolis, MN
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Palo Alto, California 94301
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Palo Alto, CA
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Pittsburgh, Pennsylvania 15212
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Salt Lake City, Utah 84143
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Salt Lake City, UT
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