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

January 29, 2019 updated by: CardioDx

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 (ASGES) testing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

713

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Warner Family Practice
    • Georgia
      • Hiawassee, Georgia, United States, 30546
        • Synergy Health
      • Suwanee, Georgia, United States, 30024
        • John's Creek Primary Care
    • Kentucky
      • Mount Sterling, Kentucky, United States, 40353
        • Paul McLaughlin, MD - Family Practice
    • Louisiana
      • Simmesport, Louisiana, United States, 71369
        • KD Health and Wellness Center
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Doctors for Health
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • TIMA Wellness
    • Ohio
      • Dayton, Ohio, United States, 45402
        • Dayton Internal Medicine
      • Youngstown, Ohio, United States, 44505
        • Northside Medical Center
    • Texas
      • Bells, Texas, United States, 75414
        • Bells Medical Clinic
      • Bonham, Texas, United States, 75418
        • Family Care Clinic
      • Dallas, Texas, United States, 75218
        • Aldrich Internal Medicine
      • Hurst, Texas, United States, 76054
        • Texas Familicare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients presenting to their primary clinician's office with chest pain suggestive of obstructive coronary artery disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Receiving Corus CAD (ASGES)
Patients receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD
Diagnostic test: CORUS CAD (ASGES)
Age/Sex/Gene Expression Score - ASGES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To describe referral patterns for cardiac care and testing within 1 month after gene expression testing.
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioDx

Investigators

  • Principal Investigator: Mark Monane, MD, CardioDx, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

August 29, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (ESTIMATE)

August 31, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX_000015
  • PRESET (OTHER: CardioDx)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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