Ignite Creation Date:
2024-05-06 @ 12:30 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01594411
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2012-04-20
Brief Title:
PCP Use of a Gene Expression Test Corus CAD or ASGES in Coronary Artery Disease Diagnosis
Sponsor:
CardioDx
Organization:
CardioDx
Study Overview
Official Title:
Investigation of a Molecular Personalized Coronary Gene Expression Test Corus CAD or ASGES on Primary Care Practice Pattern
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT-PCP
Brief Summary:
This is a prospective multi-center study examining the clinical impact of the Corus CAD AgeSexGene Expression score - ASGES assay in approximately 250 evaluable subjects with no history of obstructive coronary artery disease who now present with chest pain or anginal-equivalent symptoms to a primary care physician PCP for evaluation
Detailed Description:
In symptomatic patients with or without prior cardiac testing the PCP will initially decide the subjects pretest probability for coronary artery disease CAD based on the subjects risk factors and quality of chest pain typical or atypical or anginal equivalent eg jaw arm pain or unexplained shortness of breath and consider the results of prior testing if applicable The initial questionnaire will capture the PCPs initial clinical impression and decision preliminary decision on how to further evaluate and manage the patient A Corus CAD AgeSexGene Expression score - ASGES assay will be performed at the PCPs office After the PCP has received the Corus CAD ASGES result approximately 2-3 days later the PCP will decide on the appropriate evaluation and management of the patient final decision using the Corus CAD ASGES result in conjunction with hisher clinical impression andor other clinical data available The primary aim of this study is to evaluate whether the Corus CAD ASGES test results is associated with a change in the PCPs diagnostic evaluation and management of patients as compared to their initial testing and treatment decisions
Since it takes approximately two days for the physician to receive the result of the Corus CAD ASGES symptomatic subjects with unstable angina or suspicion for myocardial infarction will be excluded from the study
A follow-up phone call and a detailed questionnaire will be performed at 30 15 days from the time of blood draw to assess the triage decision such as referral to any subspecialists cardiologist gastroenterologist and pulmonologist cardiac diagnostic tests performed cardiac procedures performed and results of these cardiac tests and procedures
Since it takes approximately two days for the physician to receive the result of the Corus CAD ASGES symptomatic subjects with unstable angina or suspicion for myocardial infarction will be excluded from the study
A follow-up phone call and a detailed questionnaire will be performed at 30 15 days from the time of blood draw to assess the triage decision such as referral to any subspecialists cardiologist gastroenterologist and pulmonologist cardiac diagnostic tests performed cardiac procedures performed and results of these cardiac tests and procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IMPACT-PCP | OTHER | CardioDx | None |