NCT01677156

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
713

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

2.1 years

First QC Date

August 29, 2012

Last Update Submit

January 29, 2019

Conditions

Chest PainCoronary Artery DiseaseCardiovascular DiseasesCoronary Heart DiseaseAngina PectorisCADCVDCHD

Keywords

ASGESCorus CADAge/Sex/Gene Expression ScoreGene ExpressionGESCADCVDCHDPrecision MedicineClinical UtilityRegistryCoronary Artery DiseaseAngina PectorisChest PainCardiovascular DiseaseCoronary Heart DiseasePRESET

Outcome Measures

Primary Outcomes (1)

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

    1 month

Secondary Outcomes (1)

  • 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

Study Arms (1)

Receiving Corus CAD (ASGES)

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

Diagnostic Test: CORUS CAD (ASGES)

Interventions

CORUS CAD (ASGES)DIAGNOSTIC_TEST

Age/Sex/Gene Expression Score - ASGES

Receiving Corus CAD (ASGES)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Symptoms suggestive of CAD, according to the opinion of the site registry clinician
  • Receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD
  • Age \>= 18 years
  • Willing and able to provide written informed consent

You may not qualify if:

  • History of myocardial infarction (MI)
  • Current MI or acute coronary syndrome
  • Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
  • Known/documented CAD
  • Diabetes Mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Warner Family Practice

Chandler, Arizona, 85224, United States

Location

Synergy Health

Hiawassee, Georgia, 30546, United States

Location

John's Creek Primary Care

Suwanee, Georgia, 30024, United States

Location

Paul McLaughlin, MD - Family Practice

Mount Sterling, Kentucky, 40353, United States

Location

KD Health and Wellness Center

Simmesport, Louisiana, 71369, United States

Location

Doctors for Health

Omaha, Nebraska, 68130, United States

Location

TIMA Wellness

Greensboro, North Carolina, 27405, United States

Location

Dayton Internal Medicine

Dayton, Ohio, 45402, United States

Location

Northside Medical Center

Youngstown, Ohio, 44505, United States

Location

Bells Medical Clinic

Bells, Texas, 75414, United States

Location

Family Care Clinic

Bonham, Texas, 75418, United States

Location

Aldrich Internal Medicine

Dallas, Texas, 75218, United States

Location

Texas Familicare

Hurst, Texas, 76054, United States

Location

Related Publications (2)

  • 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.

    PMID: 27993573BACKGROUND

  • 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.

    PMID: 29210056DERIVED

Related Links

MeSH Terms

Conditions

Chest PainCoronary Artery DiseaseCardiovascular DiseasesCoronary DiseaseAngina Pectoris

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Michael Zapien, MS

    CardioDx, Inc.

    STUDY DIRECTOR

  • Mark Monane, MD

    CardioDx, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

August 31, 2012

Study Start

August 1, 2012

Primary Completion

September 1, 2014

Study Completion

October 1, 2015

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

US(13)