Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500708
Status:
COMPLETED
Last Update Posted:
2017-10-19
First Post:
2007-07-11
Brief Title:
Diagnostic Investigation of Sudden Cardiac Event Risk
Sponsor:
CardioDx
Organization:
CardioDx
Study Overview
Official Title:
Identifying Markers That Predict Ventricular Arrhythmia Risk
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:
DISCERN
Brief Summary:
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
Detailed Description:
This is a prospective multi-center observational study The research will be performed in three phases each using distinct patient cohorts
Phase I Discovery - genesbiomarkersclinical factors Phase II Algorithm Development Phase III Assay Validation
The final algorithm Assay may incorporate a combination of factors including genetic markers biomarkers and clinical factors 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 institutions standard patient care
Phase I Discovery - genesbiomarkersclinical factors Phase II Algorithm Development Phase III Assay Validation
The final algorithm Assay may incorporate a combination of factors including genetic markers biomarkers and clinical factors 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 institutions standard patient care
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 |
|---|---|---|---|
| DISCERN | OTHER | CardioDx | None |