Trials / Completed
CompletedNCT01486030
Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD (or ASGES) Diagnostic Test
Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD Diagnostic Test (Age, Sex, Gene Expression Score ASGES).
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- CardioDx · Industry
- Sex
- All
- Age
- 45 Years – 75 Years
- Healthy volunteers
- Not accepted
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 (Age/Sex/Gene 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 (Age/Sex/Gene 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.
Conditions
- Coronary Artery Disease
- Angina Pectoris
- Chest Pain
- Cardiovascular Diseases
- Coronary Heart Disease
- CAD
- CVD
- CHD
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Corus CAD (ASGES) | Age/Sex/Gene Expression Score - ASGES |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2011-12-06
- Last updated
- 2019-01-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01486030. Inclusion in this directory is not an endorsement.