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A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD in Real World Clinical Care Settings (PRESET)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01677156
First Posted: August 31, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CardioDx
  Purpose
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 testing.

Condition Intervention
Chest Pain Coronary Artery Disease Cardiovascular Diseases Coronary Heart Disease Angina Pectoris CAD CVD CHD Diagnostic Test: CORUS CAD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by CardioDx:

Primary Outcome Measures:
  • To describe referral patterns for cardiac care and testing within 1 month after gene expression testing. [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 713
Study Start Date: August 2012
Study Completion Date: October 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Receiving Corus CAD
Patients receiving Corus CAD to aid in the diagnosis of obstructive CAD
Diagnostic Test: CORUS CAD
Age/Sex/Gene Expression Score

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients presenting to their primary clinician's office with chest pain suggestive of obstructive coronary artery disease.
Criteria

Inclusion Criteria:

  1. Symptoms suggestive of CAD, according to the opinion of the site registry clinician
  2. Receiving Corus CAD 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677156


Locations
United States, Arizona
Warner Family Practice
Chandler, Arizona, United States, 85224
United States, Georgia
Synergy Health
Hiawassee, Georgia, United States, 30546
John's Creek Primary Care
Suwanee, Georgia, United States, 30024
United States, Kentucky
Paul McLaughlin, MD - Family Practice
Mount Sterling, Kentucky, United States, 40353
United States, Louisiana
KD Health and Wellness Center
Simmesport, Louisiana, United States, 71369
United States, Nebraska
Doctors for Health
Omaha, Nebraska, United States, 68130
United States, North Carolina
TIMA Wellness
Greensboro, North Carolina, United States, 27405
United States, Ohio
Dayton Internal Medicine
Dayton, Ohio, United States, 45402
Northside Medical Center
Youngstown, Ohio, United States, 44505
United States, Texas
Bells Medical Clinic
Bells, Texas, United States, 75414
Family Care Clinic
Bonham, Texas, United States, 75418
Aldrich Internal Medicine
Dallas, Texas, United States, 75218
Texas Familicare
Hurst, Texas, United States, 76054
Sponsors and Collaborators
CardioDx
Investigators
Study Director: Michael Zapien, MS CardioDx, Inc.
Principal Investigator: Mark Monane, MD CardioDx, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT01677156     History of Changes
Other Study ID Numbers: CDX_000015
PRESET ( Other Identifier: CardioDx )
First Submitted: August 29, 2012
First Posted: August 31, 2012
Last Update Posted: October 12, 2017
Last Verified: October 2017

Keywords provided by CardioDx:
ASGES
Corus CAD
Age/Sex/Gene Expression Score
Gene Expression
GES
CAD
CVD
CHD
Precision Medicine
Clinical Utility
Registry
Coronary Artery Disease
Angina Pectoris
Chest Pain
Cardiovascular Disease
Coronary Heart Disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Chest Pain
Angina Pectoris
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms