Utility of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Cardiology Practice Pattern

NCT01251302 | Completed

• 2 other identifiers: CDX_000011IMPACT-CARD
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate whether the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay changes the diagnostic testing pattern in patients referred to a cardiologist for the evaluation of chest pain or anginal equivalent symptoms.

Conditions

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

Keywords

Corus CAD; Age/Sex/Gene Expression Score; Molecular Genetics; Atherosclerosis; ASGES; Gene Expression; GES; CAD; CVD; CHD; Clinical Utility; Precision Medicine; Coronary Artery Disease; Angina Pectoris; Chest Pain; Cardiovascular Disease; Coronary Heart Disease; IMPACT; IMPACT-CARD

Outcome Measures

Primary Outcomes (2)

• Change in management practice pattern between preliminary and after Corus CAD (ASGES) decision

  Change in management pattern comparing the preliminary and after Corus CAD (ASGES) decision will be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories: 1. No further cardiac testing or treatment 2. Medical therapy for angina or non-cardiac chest pain 3. Stress testing with or without imaging 4. CT angiography 5. Invasive cardiac catheterization

  Up to 7 days

• Change in management practice pattern between after Corus CAD decision and historical cohort.

  Change in management pattern comparing the Corus CAD (ASGES) driven decision and the historical cohort ill be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories: 1. No further cardiac testing or treatment 2. Medical therapy for angina or non-cardiac chest pain 3. Stress testing with or without imaging 4. CT angiography 5. Invasive cardiac catheterization

  up to 195 days

Study Arms (2)

Prospective Cohort

Patient presenting with chest pain or anginal equivalent and receiving a resulted age, sex and gene expression score (ASGES) to assist in diagnosis.

Diagnostic Test: Corus CAD (ASGES)

Retrospective Cohort

Patients presenting with chest pain or anginal equivalent who did not receive an age, sex and gene expression score (ASGES) to assist in diagnosis. Note: this cohort was historical.

Interventions

Corus CAD (ASGES) DIAGNOSTIC_TEST

Age/Sex/Gene Expression Score - ASGES

Prospective Cohort

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will enroll a patient population that present with chest pain or anginal equivalent symptoms who are referred to a cardiologist for evaluation.

You may qualify if:

• Stable chest pain, typical or atypical angina or anginal equivalent
• The patient has signed the appropriate Institutional Review Board approved Informed Consent Form.

You may not qualify if:

• History of myocardial infarction
• Current myocardial infarct (MI) or acute coronary syndrome
• Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
• Any previous coronary revascularization
• Any individuals with:
• Diabetes
• Suspected unstable angina
• Systemic infections
• Systemic inflammatory conditions
• Any individuals currently taking:
• Steroids
• Immunosuppressive agents
• Chemotherapeutic agents
• Recipient of any organ transplant

Sponsors & Collaborators

• CardioDx: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• McPherson JA, Davis K, Yau M, Beineke P, Rosenberg S, Monane M, Fredi JL. The clinical utility of gene expression testing on the diagnostic evaluation of patients presenting to the cardiologist with symptoms of suspected obstructive coronary artery disease: results from the IMPACT (Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern) trial. Crit Pathw Cardiol. 2013 Jun;12(2):37-42. doi: 10.1097/HPC.0b013e3182822bd0.

  PMID: 23680805 RESULT

Biospecimen

Retention: NONE RETAINED

PaxGene tube for RNA collected

MeSH Terms

Conditions

Angina Pectoris; Coronary Artery Disease; Chest Pain; Cardiovascular Diseases; Coronary Disease; Atherosclerosis; Tooth, Impacted

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Zapien, MS

  CardioDx, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 1, 2010
• Study Start: November 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

US (1)