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

August 29, 2012
August 19, 2014
August 2012
September 2014   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT01677156 on ClinicalTrials.gov Archive Site
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 ]
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A Registry to Evaluate Patterns of Care Associated With the Use of Corus® CAD in Real World Clinical Care Settings
The PRESET Registry: A Registry to Evaluate Patterns of Care Associated With the Use of Corus® CAD in Real World Clinical Care Settings

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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

  • Chest Pain
  • Coronary Artery Disease
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Receiving Corus® CAD
Patients receiving Corus® CAD to aid in the diagnosis of obstructive CAD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
September 2015
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01677156
CDX000015
No
CardioDx
CardioDx
Not Provided
Not Provided
CardioDx
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP