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

NCT01486030 | Completed

• 2 other identifiers: CDX_000012EXERCISE
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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 (Age/Sex/Gene Expression score - ASGES) test in subject with known obstructive coronary artery disease (CAD) and in control subjects (without known CAD).

Conditions

Coronary Artery Disease; Angina Pectoris; Chest Pain; Cardiovascular Diseases; Coronary Heart Disease; CAD; CVD; CHD

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

Outcome Measures

Primary Outcomes (1)

• Age/Sex/Gene expression score (ASGES) difference between peak exercise and baseline

  up to 1 months

Interventions

Corus CAD (ASGES) DIAGNOSTIC_TEST

Age/Sex/Gene Expression Score - ASGES

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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:

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

Sponsors & Collaborators

• CardioDx: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic Research Unit

Jacksonville, Florida, 32224, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

RNA PAXgene

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Chest Pain; Cardiovascular Diseases; Coronary Disease; Atherosclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Michael Zapien, MS

  CardioDx

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: December 6, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

US (1)