Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500617
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2007-07-11
Brief Title:
Personalized Risk Evaluation and Diagnosis Using Corus CAD or ASGES in the Coronary Tree
Sponsor:
CardioDx
Organization:
CardioDx
Study Overview
Official Title:
Identification of Gene Expression Patterns in Circulating Cells That Predict the Presence of Coronary Artery Disease
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:
PREDICT
Brief Summary:
The PREDICT study is to develop and validate a diagnostic blood ASGES age sex gene expression score or Corus CAD for atherosclerotic coronary artery disease CAD The Corus CAD AgeSexGene Expression score - ASGES will use quantitative real-time PCR RT-PCR to quantify the expression of multiple genes from circulating peripheral blood cells to assess the presence of clinically significant CAD in a patient
Detailed Description:
The purpose of the PREDICT study is to develop and validate a diagnostic blood ASGES age sex gene expression score or Corus CAD for atherosclerotic coronary artery disease CAD The Corus CAD AgeSexGene Expression score - ASGES will use quantitative real-time PCR RT-PCR to quantify the expression of multiple genes from circulating peripheral blood cells to assess the presence of clinically significant CAD in a patient
This is a prospective multi-center observational study Participation in the study does not alter clinical care The only procedure required by the protocol is collection of a research blood sample All other data collected will be in accordance with each participating institutions standard patient care
The study is divided into four sequential segments with unique subjects and goals ASGES Corus CAD discovery segment 1 ASGES Corus CAD development segment 2 ASGES Corus CAD validation segment 3 and additional ASGES Corus CAD testing segment 4 The primary analysis will be performed during the third segment of the study using a subset of the enrolled subjects primary subjects Primary subjects will be defined by additional eligibility criteria beyond the general eligibility criteria required for enrollment in the overall study The additional post-enrollment eligibility criteria will be based on clinical and demographic factors that are found during the course of the study to affect the expression of genes used in the ASGES Corus CAD Such factors will be identified during gene discovery and algorithm development The post-enrollment eligibility criteria will be defined prior to the beginning of the ASGES Corus CAD validation segment of the study
In addition three substudies are planned and will enroll up to 1500 subjects
The first substudy will include subjects undergoing cardiac CT angiography CTA and aims to determine how gene expression correlates with total coronary atheroma burden as measured by CTA
The second substudy examines sample handling and shipping conditions and does not affect the treatment of the subjects
The third substudy will focus on additional algorithm development and validation in a non-diabetic female patient population
This is a prospective multi-center observational study Participation in the study does not alter clinical care The only procedure required by the protocol is collection of a research blood sample All other data collected will be in accordance with each participating institutions standard patient care
The study is divided into four sequential segments with unique subjects and goals ASGES Corus CAD discovery segment 1 ASGES Corus CAD development segment 2 ASGES Corus CAD validation segment 3 and additional ASGES Corus CAD testing segment 4 The primary analysis will be performed during the third segment of the study using a subset of the enrolled subjects primary subjects Primary subjects will be defined by additional eligibility criteria beyond the general eligibility criteria required for enrollment in the overall study The additional post-enrollment eligibility criteria will be based on clinical and demographic factors that are found during the course of the study to affect the expression of genes used in the ASGES Corus CAD Such factors will be identified during gene discovery and algorithm development The post-enrollment eligibility criteria will be defined prior to the beginning of the ASGES Corus CAD validation segment of the study
In addition three substudies are planned and will enroll up to 1500 subjects
The first substudy will include subjects undergoing cardiac CT angiography CTA and aims to determine how gene expression correlates with total coronary atheroma burden as measured by CTA
The second substudy examines sample handling and shipping conditions and does not affect the treatment of the subjects
The third substudy will focus on additional algorithm development and validation in a non-diabetic female patient population
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 |
|---|---|---|---|
| PREDICT | OTHER | CardioDx | None |