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

NCT ID: NCT01677156

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

713 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Chest Pain Coronary Artery Disease Cardiovascular Diseases Coronary Heart Disease Angina Pectoris CAD CVD CHD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Receiving Corus CAD (ASGES)

Patients receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD

CORUS CAD (ASGES)

Intervention Type DIAGNOSTIC_TEST

Age/Sex/Gene Expression Score - ASGES

Interventions

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CORUS CAD (ASGES)

Age/Sex/Gene Expression Score - ASGES

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CardioDx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Zapien, MS

Role: STUDY_DIRECTOR

CardioDx, Inc.

Mark Monane, MD

Role: PRINCIPAL_INVESTIGATOR

CardioDx, Inc.

Locations

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Warner Family Practice

Chandler, Arizona, United States

Site Status

Synergy Health

Hiawassee, Georgia, United States

Site Status

John's Creek Primary Care

Suwanee, Georgia, United States

Site Status

Paul McLaughlin, MD - Family Practice

Mount Sterling, Kentucky, United States

Site Status

KD Health and Wellness Center

Simmesport, Louisiana, United States

Site Status

Doctors for Health

Omaha, Nebraska, United States

Site Status

TIMA Wellness

Greensboro, North Carolina, United States

Site Status

Dayton Internal Medicine

Dayton, Ohio, United States

Site Status

Northside Medical Center

Youngstown, Ohio, United States

Site Status

Bells Medical Clinic

Bells, Texas, United States

Site Status

Family Care Clinic

Bonham, Texas, United States

Site Status

Aldrich Internal Medicine

Dallas, Texas, United States

Site Status

Texas Familicare

Hurst, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27993573 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29210056 (View on PubMed)

Related Links

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Other Identifiers

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PRESET

Identifier Type: OTHER

Identifier Source: secondary_id

CDX_000015

Identifier Type: -

Identifier Source: org_study_id

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