A Registry to Evaluate Patterns of Care Associated With the Use of Corus® CAD in Real World Clinical Care Settings (PRESET)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CardioDx
ClinicalTrials.gov Identifier:
NCT01677156
First received: August 29, 2012
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

Though the diagnostic properties of Corus® CAD have been evaluated in previous observational studies, there are limited data regarding how primary care clinicians are using the results of the test in the care and management of patients with angina. This registry is designed to examine the relationship between the Corus CAD score and patterns of care regarding diagnostic testing in real world clinical care settings.

Atherosclerotic coronary artery disease (CAD) is the most common cause of morbidity and mortality worldwide. CAD affects 16.5 million persons in the US. Diagnosing CAD is not straightforward and poses an enormous burden on the health care system. The most common symptom of CAD is chest pain (angina), however, only 10%-30% of chest pain and related symptoms are due to CAD. Though there are several diagnostic tests for CAD (e.g., coronary angiography, stress testing, nuclear myocardial perfusion imaging (MPI)), each has its limitations, including invasiveness, safety risks (e.g., bleeding, radiation exposure), expense, lack of accuracy, subjectivity in evaluation and interpretation of findings, and lack of availability in all geographic regions.

Recent scientific findings demonstrate that multiple genes are activated in circulating blood cells in patients with CAD. A gene expression test that detects activated and/or deactivated genes could therefore serve as a tool in aiding the diagnosis of CAD. The Corus® CAD test (henceforth, "Corus CAD") is a validated quantitative in vitro diagnostic test, performed in a single Clinical Laboratory Improvement Amendments (CLIA ) laboratory at CardioDx, Inc., using the gene expression level of 23 genes from peripheral blood specimens to assess the likelihood of a subject having at least a 50% coronary artery stenosis. Corus CAD incorporates the expression levels of these genes, using a validated algorithm with weighted functions, to generate a quantitative score and is indicated for use in stable patients with typical or atypical symptoms suggestive of CAD (e.g., chest pain, shortness of breath, heartburn, fatigue on exertion). The test is non-invasive (involving simple venipuncture), and as the results are evaluated at one laboratory, there is minimal potential variability in the analysis of findings.


Condition
Chest Pain
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The PRESET Registry: A Registry to Evaluate Patterns of Care Associated With the Use of Corus® CAD in Real World Clinical Care Settings

Resource links provided by NLM:


Further study details as provided by CardioDx:

Primary Outcome Measures:
  • To describe referral patterns for cardiac care and testing within 1 month after gene expression testing. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe follow up events (eg., diagnoses, non-cardiac testing, medication use, MACE) at 12 months follow up within gene expression test strata. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: August 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Receiving Corus® CAD
Patients receiving Corus® CAD to aid in the diagnosis of obstructive CAD

Detailed Description:

Though the diagnostic properties of Corus® CAD have been evaluated in previous observational studies, there are limited data regarding how primary care clinicians are using the results of the test in the care and management of patients with angina. This registry is designed to examine the relationship between the Corus CAD score and patterns of care regarding diagnostic testing in real world clinical care settings.

Atherosclerotic coronary artery disease (CAD) is the most common cause of morbidity and mortality worldwide. CAD affects 16.5 million persons in the US. Diagnosing CAD is not straightforward and poses an enormous burden on the health care system. The most common symptom of CAD is chest pain (angina), however, only 10%-30% of chest pain and related symptoms are due to CAD. Though there are several diagnostic tests for CAD (e.g., coronary angiography, stress testing, nuclear myocardial perfusion imaging (MPI)), each has its limitations, including invasiveness, safety risks (e.g., bleeding, radiation exposure), expense, lack of accuracy, subjectivity in evaluation and interpretation of findings, and lack of availability in all geographic regions.

Recent scientific findings demonstrate that multiple genes are activated in circulating blood cells in patients with CAD. A gene expression test that detects activated and/or deactivated genes could therefore serve as a tool in aiding the diagnosis of CAD. The Corus® CAD test (henceforth, "Corus CAD") is a validated quantitative in vitro diagnostic test, performed in a single Clinical Laboratory Improvement Amendments (CLIA ) laboratory at CardioDx, Inc., using the gene expression level of 23 genes from peripheral blood specimens to assess the likelihood of a subject having at least a 50% coronary artery stenosis. Corus CAD incorporates the expression levels of these genes, using a validated algorithm with weighted functions, to generate a quantitative score and is indicated for use in stable patients with typical or atypical symptoms suggestive of CAD (e.g., chest pain, shortness of breath, heartburn, fatigue on exertion). The test is non-invasive (involving simple venipuncture), and as the results are evaluated at one laboratory, there is minimal potential variability in the analysis of findings.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients presenting to their primary clinician's office with chest pain suggestive of obstructive coronary artery disease.

Criteria

Inclusion Criteria:

  1. Symptoms suggestive of CAD, according to the opinion of the site registry clinician
  2. Receiving Corus CAD to aid in the diagnosis of obstructive CAD
  3. Age >= 18 years
  4. Willing and able to provide written informed consent

Exclusion Criteria:

  1. History of myocardial infarction (MI)
  2. Current MI or acute coronary syndrome
  3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
  4. Known/documented CAD
  5. Diabetes Mellitus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677156

Locations
United States, Georgia
John's Creek Primary Care
Suwanee, Georgia, United States, 30024
United States, Louisiana
KD Health and Wellness Center
Simmesport, Louisiana, United States, 71369
United States, Ohio
Northside Medical Center
Youngstown, Ohio, United States, 44505
United States, Texas
Bells Medical Clinic
Bells, Texas, United States, 75414
Family Care Clinic
Bonham, Texas, United States, 75418
Texas Familicare
Hurst, Texas, United States, 76054
Sponsors and Collaborators
CardioDx
  More Information

No publications provided

Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT01677156     History of Changes
Other Study ID Numbers: CDX000015
Study First Received: August 29, 2012
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chest Pain
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014