Ignite Creation Date:
2024-05-06 @ 12:21 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01557855
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2012-03-16
Brief Title:
Investigation of a Novel Gene Expression Test ASGES or Corus CAD for Diagnosis of Obstructive Coronary Artery Disease
Sponsor:
CardioDx
Organization:
CardioDx
Study Overview
Official Title:
Enhanced Assessment of Chest Pain and Related Symptoms in the Primary Care Setting Through the Use of a Novel Personalized Medicine Genomic Test Results From a Prospective Registry Study
Status:
COMPLETED
Status Verified Date:
2019-01
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:
REGISTRY-I
Brief Summary:
The objective of this study is to collect data on the commercial use of Corus CAD AgeSexGene Expression score - ASGES blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients Corus Score and to better understand patient management patterns for clinicians ordering the test
Detailed Description:
This is a prospective multicenter observational registry collecting and analyzing commercial utilization data of the Corus CAD assay Test also known as AgeSexGene Expression score ASGES The study will prospectively enroll approximately 670 evaluable subjects from qualified sites and evaluate the rate of referral versus Corus CAD ASGES score as continuous variables
Objective of the study is to assess whether the score provided by the Corus CAD AgeSexGene Expression score - ASGES test has an effect on the Primary Care Physicians patient management and referral patterns once received
1 No further cardiac testing or treatment
2 Medical therapy for angina or non-cardiac chest pain
3 Referral to a cardiologist for stress testing with or without imaging CT angiography or invasive cardiac catheterization
Since it takes approximately two days for the physician to receive the result of the Corus CAD AgeSexGene Expression score - ASGES initial diagnostic testing will reflect local standard of care
Objective of the study is to assess whether the score provided by the Corus CAD AgeSexGene Expression score - ASGES test has an effect on the Primary Care Physicians patient management and referral patterns once received
1 No further cardiac testing or treatment
2 Medical therapy for angina or non-cardiac chest pain
3 Referral to a cardiologist for stress testing with or without imaging CT angiography or invasive cardiac catheterization
Since it takes approximately two days for the physician to receive the result of the Corus CAD AgeSexGene Expression score - ASGES initial diagnostic testing will reflect local standard of 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 |
|---|---|---|---|
| REGISTRY-I | OTHER | CardioDx | None |