Personalized Risk Evaluation and Diagnosis (Using Corus CAD or ASGES) in the Coronary Tree
PREDICT
Identification of Gene Expression Patterns in Circulating Cells That Predict the Presence of Coronary Artery Disease
2 other identifiers
observational
4,350
1 country
10
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 (Age/Sex/Gene 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2007
Longer than P75 for all trials
10 active sites
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
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 11, 2007
CompletedFirst Posted
Study publicly available on registry
July 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJanuary 31, 2019
January 1, 2019
2.5 years
July 11, 2007
January 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Algorithm AUC >0.50
The primary analysis will be performed during the third segment of the study using a subset of the enrolled subjects ("primary subjects"). The primary endpoint for the PREDICT study is a validated algorithm that can accurately classify subjects with and without any coronary artery lesion with a ≥50% diameter stenosis, as measured by Core Laboratory blinded quantitative coronary angiography. In evaluating this endpoint, subjects will be classified as either cases or controls. The endpoint will be assessed by calculating the area under the curve (AUC) for the algorithm score, and testing against an AUC = 0.50 to determine clinical utility, using an alpha level of 0.05 (two-sided).
30days
Study Arms (4)
segment 1
Gene discovery blood draw
sement 2
Assay development blood draw
segment 3
Assay validation blood draw
segment 4
Additional assay testing blood draw (Note: post discovery diabetic subjects assigned to this group)
Interventions
Age/Sex/Gene Expression Score - ASGES
Eligibility Criteria
Patients undergoing clinically indicated invasive coronary artery angiogram or CT angiogram.
You may qualify if:
- Referral for a coronary angiogram (either invasive X-ray angiography or coronary CTA)
- Any one of the following clinical syndromes:
- chest pain syndrome, stable angina, or anginal equivalent suggesting myocardial ischemia
- low-risk unstable angin, or
- asymptomatic individuals with a high probability of CAD
You may not qualify if:
- History of myocardial infarction or known CAD
- Current Myocardial Infarct (MI), acute coronary syndrome with high-risk features or unstable angina with high-risk features
- New York Heart Association (NYHA) class III or IV congestive
- Inability to give informed congestive heart failures
- Severe left ventricular systolic dysfunction (LVEF\<35%)
- Severe regurgitant or stenotic cardiac valve lesion
- Active or chronic systemic infection
- Rheumatologic, autoimmune or hematologic conditions
- Any organ transplant
- Immunosuppressive therapy
- Chemotherapy in the preceding year
- Major blood or blood product transfusion in the preceding 2 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CardioDxlead
Study Sites (10)
Alaska Heart Institute
Anchorage, Alaska, 99508, United States
CV Medical Group Southern California
Beverly Hills, California, 90210, United States
Scripps HealthCare
La Jolla, California, 92037, United States
Washington Hospital Medical Center
Washington D.C., District of Columbia, 20010, United States
Fuqua Heart Center of Atlanta
Atlanta, Georgia, 30309, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Allegheny Hospital
Pittsburgh, Pennsylvania, 15212, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Intermountain HealthCare
Salt Lake City, Utah, 84107, United States
Related Publications (7)
Rosenberg S, Elashoff MR, Beineke P, Daniels SE, Wingrove JA, Tingley WG, Sager PT, Sehnert AJ, Yau M, Kraus WE, Newby LK, Schwartz RS, Voros S, Ellis SG, Tahirkheli N, Waksman R, McPherson J, Lansky A, Winn ME, Schork NJ, Topol EJ; PREDICT (Personalized Risk Evaluation and Diagnosis in the Coronary Tree) Investigators. Multicenter validation of the diagnostic accuracy of a blood-based gene expression test for assessing obstructive coronary artery disease in nondiabetic patients. Ann Intern Med. 2010 Oct 5;153(7):425-34. doi: 10.7326/0003-4819-153-7-201010050-00005.
PMID: 20921541RESULTVoros S, Elashoff MR, Wingrove JA, Budoff MJ, Thomas GS, Rosenberg S. A peripheral blood gene expression score is associated with atherosclerotic Plaque Burden and Stenosis by cardiovascular CT-angiography: results from the PREDICT and COMPASS studies. Atherosclerosis. 2014 Mar;233(1):284-90. doi: 10.1016/j.atherosclerosis.2013.12.045. Epub 2014 Jan 20.
PMID: 24529158RESULTBeineke P, Fitch K, Tao H, Elashoff MR, Rosenberg S, Kraus WE, Wingrove JA; PREDICT Investigators. A whole blood gene expression-based signature for smoking status. BMC Med Genomics. 2012 Dec 3;5:58. doi: 10.1186/1755-8794-5-58.
PMID: 23210427RESULTLansky A, Elashoff MR, Ng V, McPherson J, Lazar D, Kraus WE, Voros S, Schwartz RS, Topol EJ. A gender-specific blood-based gene expression score for assessing obstructive coronary artery disease in nondiabetic patients: results of the Personalized Risk Evaluation and Diagnosis in the Coronary Tree (PREDICT) trial. Am Heart J. 2012 Sep;164(3):320-6. doi: 10.1016/j.ahj.2012.05.012. Epub 2012 Jul 24.
PMID: 22980297RESULTRosenberg S, Elashoff MR, Lieu HD, Brown BO, Kraus WE, Schwartz RS, Voros S, Ellis SG, Waksman R, McPherson JA, Lansky AJ, Topol EJ; PREDICT Investigators. Whole blood gene expression testing for coronary artery disease in nondiabetic patients: major adverse cardiovascular events and interventions in the PREDICT trial. J Cardiovasc Transl Res. 2012 Jun;5(3):366-74. doi: 10.1007/s12265-012-9353-z. Epub 2012 Mar 7.
PMID: 22396313RESULTElashoff MR, Wingrove JA, Beineke P, Daniels SE, Tingley WG, Rosenberg S, Voros S, Kraus WE, Ginsburg GS, Schwartz RS, Ellis SG, Tahirkheli N, Waksman R, McPherson J, Lansky AJ, Topol EJ. Development of a blood-based gene expression algorithm for assessment of obstructive coronary artery disease in non-diabetic patients. BMC Med Genomics. 2011 Mar 28;4:26. doi: 10.1186/1755-8794-4-26.
PMID: 21443790RESULTDaniels SE, Beineke P, Rhees B, McPherson JA, Kraus WE, Thomas GS, Rosenberg S. Biological and analytical stability of a peripheral blood gene expression score for obstructive coronary artery disease in the PREDICT and COMPASS studies. J Cardiovasc Transl Res. 2014 Oct;7(7):615-22. doi: 10.1007/s12265-014-9583-3. Epub 2014 Aug 14.
PMID: 25119856DERIVED
Biospecimen
whole blood, buffy coat, spun plasma, RNA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mark Monane, MD FACP CMQ
CardioDx
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2007
First Posted
July 13, 2007
Study Start
July 1, 2007
Primary Completion
January 1, 2010
Study Completion
September 1, 2011
Last Updated
January 31, 2019
Record last verified: 2019-01