Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD (or ASGES) Diagnostic Test

Completed

Conditions studied: Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CAD, CVD, CHD

In brief

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).

Key facts

Study ID

NCT01486030

Run by

CardioDx

People needed

20

Starts

2011-09-01

Expected to finish

2013-11-01

Last updated by the study team

2019-01-31

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 45-75 years old
• Able to perform an adequate exercise stress test
• Subjects with no known CAD and subjects with known CAD subjects

You may not qualify if…

• 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)**.
• 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

Where it is running

• Mayo Clinic Research Unit — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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