Ignite Creation Date:
2024-05-06 @ 12:04 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01486030
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2011-10-17
Brief Title:
Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD or ASGES Diagnostic Test
Sponsor:
CardioDx
Organization:
CardioDx
Study Overview
Official Title:
Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD Diagnostic Test Age Sex Gene Expression Score ASGES
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:
EXERCISE
Brief Summary:
This is a prospective single-center study that aims to evaluate the acute and delayed effect of exercise stress testing on the peripheral gene expression PGE levels using a predefined gene set established in the Corus CAD AgeSexGene Expression score - ASGES test in subject with known obstructive coronary artery disease CAD and in control subjects without known CAD
Detailed Description:
This is a prospective single-center study This protocol is a pilot study to investigate the effects of acute exercise by exercise stress testing modified Bruce protocol on peripheral gene expression PGE levels as measured by Corus CAD score AgeSexGene Expression score - ASGES Subjects will have blood sampling at baseline at peak exercise within 30 to 60 minutes post-exercise at 24-36 hours post-exercise The study will be stratified by presence of CAD and gender An equal number of subjects with known CAD and normal controls will be enrolled Equally an equal number of men and women will be included A screening CBC and HgbA1c will be performed to ensure the subject meets the intended use instruction for Corus CAD ASGES Data collection will include presence or absence of ECG ischemia with testing as well as heart rate and blood pressure response to exercise with other ECG and dynamic variables There will be four blood samples taken per subject as shown in the figure below
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 |
|---|---|---|---|
| EXERCISE | OTHER | CardioDx | None |