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| ID | Type | Description | Link |
|---|---|---|---|
| DISCERN | Other Identifier | CardioDx |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Gene discovery | Genome Wide Association Study (GWAS) | up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patient's with ventricular dysfunction (low ejection fraction) undergoing implantation of ICD or CRT-D for primary prevention. Patient's may be enrolled at time of implant or during follow-up in electrophysiology clinic as long as full device records are available since time of implant.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Zapien, MS | CardioDx, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Heart Institute | Anchorage | Alaska | 99508 | United States | ||
| Palo Alto Medical Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Hranitzky PM, Sehnert AJ, Blanchard JL, et al. Abstract 16410: Identification of novel genetic markers associated with lethal ventricular arrhythmias in heart failure patients: genome wide association study in the DISCERN cohort. Circulation. 2010;122. Abstract 16410. |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D002318 | Cardiovascular Diseases |
| D006333 | Heart Failure |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
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whole blood, buffy coat, spun plasma, saliva
| Palo Alto |
| California |
| 94301 |
| United States |
| Minneapolis Heart Institute and Foundation | Minneapolis | Minnesota | 55407 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| West Penn Allegheny Health System | Pittsburgh | Pennsylvania | 15212 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Intermountain Healthcare | Salt Lake City | Utah | 84111 | United States |
| D014652 | Vascular Diseases |