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

Completed

• Conditions: Coronary Artery Disease; CAD; Coronary Heart Disease; Angina Pectoris; Chest Pain; Cardiovascular Diseases; CVD; CHD
• Interventions: Diagnostic Test: CORUS CAD (ASGES)

• Registration Number: NCT01677156
• Lead Sponsor: CardioDx

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-31
• Primary Completion: 2014-09
• Study Completion: 2015-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 713

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Receiving Corus CAD (ASGES)	CORUS CAD (ASGES)	Patients receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD

Primary Outcome Measures

Name	Time	Method
To describe referral patterns for cardiac care and testing within 1 month after gene expression testing.	1 month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

Warner Family Practice; 🇺🇸 Chandler, Arizona, United States

TIMA Wellness; 🇺🇸 Greensboro, North Carolina, United States

John's Creek Primary Care; 🇺🇸 Suwanee, Georgia, United States

Synergy Health; 🇺🇸 Hiawassee, Georgia, United States

Paul McLaughlin, MD - Family Practice; 🇺🇸 Mount Sterling, Kentucky, United States

KD Health and Wellness Center; 🇺🇸 Simmesport, Louisiana, United States

Northside Medical Center; 🇺🇸 Youngstown, Ohio, United States

Doctors for Health; 🇺🇸 Omaha, Nebraska, United States

Dayton Internal Medicine; 🇺🇸 Dayton, Ohio, United States

Bells Medical Clinic; 🇺🇸 Bells, Texas, United States

Family Care Clinic; 🇺🇸 Bonham, Texas, United States

Texas Familicare; 🇺🇸 Hurst, Texas, United States

Aldrich Internal Medicine; 🇺🇸 Dallas, Texas, United States