Primary Care Providers Use of a Gene Expression Test in Coronary Artery Disease Diagnosis (IMPACT-PCP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CardioDx
ClinicalTrials.gov Identifier:
NCT01594411
First received: April 20, 2012
Last updated: April 15, 2014
Last verified: April 2014
Results First Received: September 3, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Chest Pain
Cardiovascular Disease

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects are enrolled at multiple participating primary care practices from site initiation (Apr-Jun 2012) thru January 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
327 screened, 275 met inclusion/exclusion. Subjects were excluded from the analysis set if no Corus CAD test could be resulted (7) or if additional information was available and used in making post treatment decisions (3) or did not inclusion/exclusion (discovered after research blood sample draw). Analysis set was 251.

Reporting Groups
  Description
All Subjects Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.

Participant Flow:   Overall Study
    All Subjects  
STARTED     251  
COMPLETED     249  
NOT COMPLETED     2  
Lost to Follow-up                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Sequentially enrolled subjects meeting the inclusion/exclusion criteria and have a resulted CORUS CAD test.

Reporting Groups
  Description
All Subjects Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.

Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  251  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     182  
>=65 years     69  
Age  
[units: years]
Mean ± Standard Deviation
  56.2  ± 13  
Gender  
[units: participants]
 
Female     140  
Male     111  
Region of Enrollment  
[units: participants]
 
United States     251  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  29.7  ± 6.7  
Gene Expression Score [1]
[units: unitless]
Mean ± Standard Deviation
  16  ± 10  
[1] The GES algorithm comprises expression values for 23 genes from peripheral blood cells in 6 terms, patient age, and sex. There are both sex-specific and common algorithm terms with sex-specific weights. The changes in gene expression are quantified using an algorithm that generates a GES ranging from 1 to 40. A score less than or equal to 5 indicates a low risk of underlying obstructive coronary disease.The GES has been shown to have a negative predictive value of 96% for GES less than or equal to 15 in a population referred to MPI.



  Outcome Measures

1.  Primary:   Change in Clinicians' Treatment Decision After Gene Expression Testing   [ Time Frame: pre- and post- gene expression testing results (on avaerage 2-3 days to receive GES) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Prospective design may have influenced the diagnostic strategy; but historical controls had a similar diagnostic strategy.

Possible Selection bias; we believe these pts are typical of each practice. Appropriateness of care not evaluated

 


Results Point of Contact:  
Name/Title: May Yau, Sr. Director Clinical Operations
Organization: CardioDx, Inc.
phone: 650-475-2724
e-mail: llittleford@cardiodx.com


Publications of Results:

Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT01594411     History of Changes
Other Study ID Numbers: IMPACT-PCP, CDX 000014
Study First Received: April 20, 2012
Results First Received: September 3, 2013
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board