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A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (or ASGES) in Primary Care Settings (PRESET)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01677156
First Posted: August 31, 2012
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CardioDx
August 29, 2012
August 31, 2012
October 19, 2017
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 ]
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 ASGES (age, sex,gene expression score) test strata. [ Time Frame: 12 months ]
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A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (or ASGES) in Primary Care Settings
The PRESET Registry: A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Real World Clinical Care Settings
The PRESET Registry--A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (Age/Sex/Gene Expression score - ASGES) in Real World Clinical Care Settings (PRESET)--was designed as an observational, post-market, real-world registry to evaluate patterns of care, including referrals to a cardiologist, cardiac stress testing, CT angiography, within the first month after Corus CAD testing.
The prospective PRESET Registry (NCT01677156) enrolled stable, nonacute adult patients presenting with typical or atypical symptoms suggestive of obstructive coronary artery disease from 21 US primary care practices from August 2012 to August 2014. Demographics, clinical characteristics, and Corus CAD (Age/Sex/Gene Expression score - ASGES) results (predefined as low [ASGES <15] or elevated [ASGES >15]) were collected, as were referrals to Cardiology or further functional/anatomic cardiac testing after Corus CAD (Age/Sex/Gene Expression score - ASGES) testing. Patients were followed for 1 year post ASGES testing.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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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
  • Cardiovascular Diseases
  • Coronary Heart Disease
  • Angina Pectoris
  • CAD
  • CVD
  • CHD
Diagnostic Test: CORUS CAD
Age/Sex/Gene Expression Score
Receiving Corus CAD
Patients receiving Corus CAD to aid in the diagnosis of obstructive CAD
Intervention: Diagnostic Test: CORUS CAD
Ladapo JA, Budoff M, Sharp D, Zapien M, Huang L, Maniet B, Herman L, Monane M. Clinical Utility of a Precision Medicine Test Evaluating Outpatients with Suspected Obstructive Coronary Artery Disease. Am J Med. 2017 Apr;130(4):482.e11-482.e17. doi: 10.1016/j.amjmed.2016.11.021. Epub 2016 Dec 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
713
October 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01677156
CDX_000015
PRESET ( Other Identifier: CardioDx )
No
Not Provided
Not Provided
CardioDx
CardioDx
Not Provided
Study Director: Michael Zapien, MS CardioDx, Inc.
Principal Investigator: Mark Monane, MD CardioDx, Inc.
CardioDx
October 2017