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NCT01677156 Clinical Trial

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

Coronary Artery Disease Clinical Trial

— PRESET  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01677156
Other study ID # CDX_000015
Secondary ID PRESET
Status Completed
Phase
First received
Last updated
Start date August 2012
Est. completion date October 2015

Study information
Verified date January 2019
Source CardioDx
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 713
Est. completion date October 2015
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• CORUS CAD (ASGES)
Age/Sex/Gene Expression Score - ASGES

Locations
Country Name City State
United States Bells Medical Clinic Bells Texas
United States Family Care Clinic Bonham Texas
United States Warner Family Practice Chandler Arizona
United States Aldrich Internal Medicine Dallas Texas
United States Dayton Internal Medicine Dayton Ohio
United States TIMA Wellness Greensboro North Carolina
United States Synergy Health Hiawassee Georgia
United States Texas Familicare Hurst Texas
United States Paul McLaughlin, MD - Family Practice Mount Sterling Kentucky
United States Doctors for Health Omaha Nebraska
United States KD Health and Wellness Center Simmesport Louisiana
United States John's Creek Primary Care Suwanee Georgia
United States Northside Medical Center Youngstown Ohio

Sponsors (1)
Lead Sponsor Collaborator
CardioDx

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To describe referral patterns for cardiac care and testing within 1 month after gene expression testing. 1 month
Secondary 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. 12 months
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