Coronary Artery DiseaseEXERCISENCT01486030
Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD (or ASGES) Diagnostic Test
An observational study of Coronary Artery Disease and Angina Pectoris, run by CardioDx at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris, Chest Pain
- What is being tested?
- Corus CAD (ASGES)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-diabetic subjects will be enrolled at the Department of Cardiology, Mayo Clinic, Florida. Enrollment will not be randomized. Subjects will be enrolled based on achieving an equal number of men and women, and known Coronary Artery Disease or CAD (prior history of ischemia by stress test or a coronary catheterization documenting greater than or equal to 50% stenosis in any vessels within 12 months prior to enrollment) and no known CAD (controls - prior of history of coronary catheterization documenting less than or equal to 15% stenosis in any vessels within 12 months prior to enrollment). Enrollment will be stratified as shown below:
Who may be able to join
- Ages 45-75 years old
- Able to perform an adequate exercise stress test
- Subjects with no known CAD and subjects with known CAD subjects
Who cannot join
- Known severe CAD that will be unsafe to exercise stress patient
- Current MI or high-risk acute coronary syndrome (including high-risk unstable angina
- NYHA class III or IV congestive heart failure
- Severe regurgitant or stenotic cardiac valvular lesion
- Severe left ventricular systolic dysfunction
- Active systemic infection in the preceding 2 months or chronic infection (e.g. HIV, Hepatitis B or C, Tuberculosis)**.
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- Protocol-specified rheumatologic, autoimmune or hematologic conditions
- Known or suspected diabetes mellitus or documented Hemoglobin A1C (A test for people with diabetes that monitors their average blood sugar levels over a period of two to three months) percent within last 6 months; presume normal HgbA1c (used as a standard tool to determine blood sugar control for patients with diabetes.) if none documented.
- Total WBC 11,000/ul from a CBC drawn within 7 days of enrollment
- Inadequate exercise stress test.
- Recipient of any organ transplant
- Immunosuppressive or immunomodulatory therapy including any dose of systemic corticosteroids in the preceding two months
- Chemotherapy in the preceding year
- Major surgery in the preceding 2 months
- Blood or blood product transfusion in the preceding 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Research Unit
Jacksonville, Florida, 32224
About this study
Official title: Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD Diagnostic Test (Age, Sex, Gene Expression Score ASGES).
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).
Read the 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
- Being tested
- Corus CAD (ASGES)
- Keywords
- Atherosclerosis, Corus CAD, Age/Sex/Gene Expression Score, ASGES, Gene Expression, GES, CAD, CVD, CHD, Precision Medicine, Exercise Stress Test, Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Disease, Coronary Heart Disease, EXERCISE
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Disease, Atherosclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corus CAD (ASGES)Diagnostic test
Age/Sex/Gene Expression Score - ASGES
What is being measured
The primary outcome is the main question the study is designed to answer.
Age/Sex/Gene expression score (ASGES) difference between peak exercise and baseline
Measured: up to 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Michael Zapien, MS, Study director, CardioDx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486030
- Sponsor's protocol ID
- CDX_000012
- Other IDs
- EXERCISE
- Acronym
- EXERCISE
- Status last verified
- Jan 2019
- First submitted
- 17 Oct 2011
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD Diagnostic Test (Age, Sex, Gene Expression Score ASGES).
- ClinicalTrials.gov ID
- NCT01486030
- Acronym / sponsor ID
- EXERCISE / CDX_000012
- Conditions
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CAD
- Keywords
- Atherosclerosis, Corus CAD, Age/Sex/Gene Expression Score, ASGES, Gene Expression, GES, CAD, CVD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CardioDxIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- Sep 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-diabetic subjects will be enrolled at the Department of Cardiology, Mayo Clinic, Florida. Enrollment will not be randomized. Subjects will be enrolled based on achieving an equal number of men and women, and known Coronary Artery Disease or CAD (prior history of ischemia by stress test or a coronary catheterization documenting greater than or equal to 50% stenosis in any vessels within 12 months prior to enrollment) and no known CAD (controls - prior of history of coronary catheterization documenting less than or equal to 15% stenosis in any vessels within 12 months prior to enrollment). Enrollment will be stratified as shown below:
Key inclusion criteria (3 listed)
- Ages 45-75 years old
- Able to perform an adequate exercise stress test
- Subjects with no known CAD and subjects with known CAD subjects
Key exclusion criteria (15 listed)
- Known severe CAD that will be unsafe to exercise stress patient
- Current MI or high-risk acute coronary syndrome (including high-risk unstable angina
- NYHA class III or IV congestive heart failure
- Severe regurgitant or stenotic cardiac valvular lesion
- Severe left ventricular systolic dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corus CAD (ASGES)Age/Sex/Gene Expression Score - ASGES | Diagnostic test | – |
Primary outcome
Age/Sex/Gene expression score (ASGES) difference between peak exercise and baseline
Time frame: up to 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Zapien, MS study director
CardioDx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Angina Pectoris, run by CardioDx at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age/Sex/Gene expression score (ASGES) difference between peak exercise and baseline (time frame: up to 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.