Clinical trial NCT01677156: A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (or ASGES) in Primary Care Settings
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Coronary Artery Disease
Cardiovascular Diseases
Coronary Heart Disease
Angina Pectoris
CAD
CVD
CHD
Keywords: ASGES
Corus CAD
Age/Sex/Gene Expression Score
Gene Expression
GES
CAD
CVD
CHD
Precision Medicine
Clinical Utility
Registry
Coronary Artery Disease
Angina Pectoris
Chest Pain
Cardiovascular Disease
Coronary Heart Disease
PRESET
Lead sponsor: CardioDx
Sponsor class: INDUSTRY
First posted: 2012-08-31
Enrollment: 713
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to their primary clinician's office with chest pain suggestive of obstructive coronary artery disease.

Brief summary: 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 (ASGES) testing.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Symptoms suggestive of CAD, according to the opinion of the site registry clinician
2. Receiving Corus CAD (ASGES) 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

Primary outcomes:
measure: To describe referral patterns for cardiac care and testing within 1 month after gene expression testing.
timeFrame: 1 month
Secondary outcomes:
measure: 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.
timeFrame: 12 months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Warner Family Practice
state: Arizona
city: Hiawassee
country: United States
facility: Synergy Health
state: Georgia
city: Suwanee
country: United States
facility: John's Creek Primary Care
state: Georgia
city: Mount Sterling
country: United States
facility: Paul McLaughlin, MD - Family Practice
state: Kentucky
city: Simmesport
country: United States
facility: KD Health and Wellness Center
state: Louisiana
city: Omaha
country: United States
facility: Doctors for Health
state: Nebraska
city: Greensboro
country: United States
facility: TIMA Wellness
state: North Carolina
city: Dayton
country: United States
facility: Dayton Internal Medicine
state: Ohio
city: Youngstown
country: United States
facility: Northside Medical Center
state: Ohio
city: Bells
country: United States
facility: Bells Medical Clinic
state: Texas
city: Bonham
country: United States
facility: Family Care Clinic
state: Texas
city: Dallas
country: United States
facility: Aldrich Internal Medicine
state: Texas
city: Hurst
country: United States
facility: Texas Familicare
state: Texas
Study officials:
affiliation: CardioDx, Inc.
name: Michael Zapien, MS
role: STUDY_DIRECTOR
affiliation: CardioDx, Inc.
name: Mark Monane, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ladapo JA, Budoff MJ, Sharp D, Kuo JZ, Huang L, Maniet B, Herman L, Monane M. Utility of a Precision Medicine Test in Elderly Adults with Symptoms Suggestive of Coronary Artery Disease. J Am Geriatr Soc. 2018 Feb;66(2):309-315. doi: 10.1111/jgs.15215. Epub 2017 Dec 6.