Coronary Artery DiseasePREDICTNCT00500617
Personalized Risk Evaluation and Diagnosis (Using Corus CAD or ASGES) in the Coronary Tree
An observational study of Coronary Artery Disease and Angina Pectoris, run by CardioDx at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris, Chest Pain
- What is being tested?
- Corus CAD (ASGES)
- How many people
- 4,350 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2007to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing clinically indicated invasive coronary artery angiogram or CT angiogram.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Alaska Heart Institute
Anchorage, Alaska, 99508
Fuqua Heart Center of Atlanta
Atlanta, Georgia, 30309
CV Medical Group Southern California
Beverly Hills, California, 90210
Duke University Medical Center
Durham, North Carolina, 27705
Scripps HealthCare
La Jolla, California, 92037
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Allegheny Hospital
Pittsburgh, Pennsylvania, 15212
Intermountain HealthCare
Salt Lake City, Utah, 84107
Washington Hospital Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Identification of Gene Expression Patterns in Circulating Cells That Predict the Presence of Coronary Artery Disease
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.
Read the 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 (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.
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 institution's 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.
- Conditions
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CAD
- Being tested
- Corus CAD (ASGES)
- Keywords
- Atherosclerosis, Biological Markers, Molecular Genetics, Gene Expression, GES, CAD, CVD, CHD, Clinical Validity, Precision Medicine, ASGES, CT Angiography, Corus CAD, Coronary angiorgram, Age/Sex/Gene expression Score, Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Disease, Coronary Heart Disease
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corus CAD (ASGES)Diagnostic test
Age/Sex/Gene Expression Score - ASGES
| Study group | Role | What they receive |
|---|---|---|
| segment 1 | Gene discovery blood draw Receives: Diagnostic Test: Corus CAD (ASGES) | |
| sement 2 | Assay development blood draw Receives: Diagnostic Test: Corus CAD (ASGES) | |
| segment 3 | Assay validation blood draw Receives: Diagnostic Test: Corus CAD (ASGES) | |
| segment 4 | Additional assay testing blood draw (Note: post discovery diabetic subjects assigned to this group) Receives: Diagnostic Test: Corus CAD (ASGES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 4,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Monane, MD FACP CMQ, Study chair, CardioDx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500617
- Sponsor's protocol ID
- CDX_000004
- Other IDs
- PREDICT
- Acronym
- PREDICT
- Status last verified
- Jan 2019
- First submitted
- 11 Jul 2007
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20921541Voros 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.
PubMed 24529158Beineke 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.
PubMed 23210427Lansky 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.
PubMed 22980297Rosenberg 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.
PubMed 22396313Elashoff 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.
PubMed 21443790Daniels 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.
PubMed 25119856
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Gene Expression Patterns in Circulating Cells That Predict the Presence of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00500617
- Acronym / sponsor ID
- PREDICT / CDX_000004
- Conditions
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CAD
- Keywords
- Atherosclerosis, Biological Markers, Molecular Genetics, Gene Expression, GES, CAD, CVD, CHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,350 participants (actual)
- Lead sponsor
- CardioDxIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 13 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
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 institution's 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| segment 1 | – | Diagnostic Test: Corus CAD (ASGES)Gene discovery blood draw |
| sement 2 | – | Diagnostic Test: Corus CAD (ASGES)Assay development blood draw |
| segment 3 | – | Diagnostic Test: Corus CAD (ASGES)Assay validation blood draw |
| segment 4 | – | Diagnostic Test: Corus CAD (ASGES)Additional assay testing blood draw (Note: post discovery diabetic subjects assigned to this group) |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing clinically indicated invasive coronary artery angiogram or CT angiogram.
Key inclusion criteria (5 listed)
- Referral for a coronary angiogram (either invasive X-ray angiography or coronary CTA)
- Any one of the following clinical syndromes:
Key exclusion criteria (12 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corus CAD (ASGES)Age/Sex/Gene Expression Score - ASGES | Diagnostic test | segment 1, segment 3, segment 4, sement 2 |
Primary outcome
Algorithm AUC >0.50
Time frame: 30days
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Results publication: PubMed 20921541Rosenberg 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.
- Results publication: PubMed 24529158Voros 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.
- Results publication: PubMed 23210427Beineke 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.
- Results publication: PubMed 22980297Lansky 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.
- Results publication: PubMed 22396313Rosenberg 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.
- Results publication: PubMed 21443790Elashoff 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.
- Derived from this study: PubMed 25119856Daniels 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Monane, MD FACP CMQ study chair
CardioDx
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Angina Pectoris, run by CardioDx at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Algorithm AUC >0.50 (time frame: 30days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00500617, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019; AzTrials last refreshed its copy on 2 Nov 2026.