Chest PainPRESETNCT01677156
A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (or ASGES) in Primary Care Settings
An observational study of Chest Pain and Coronary Artery Disease, run by CardioDx at 13 sites in United States.
Trial summary
The PRESET Registry--A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (Age/Sex/Gene Expression score - ASGES) in Real World Clinical Care Settings (PRESET)--was designed as an observational, post-market, real-world registry to evaluate patterns of care, including referrals to a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chest Pain, Coronary Artery Disease, Cardiovascular Diseases
- What is being tested?
- CORUS CAD (ASGES)
- How many people
- 713 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2012to Oct 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting to their primary clinician's office with chest pain suggestive of obstructive coronary artery disease.
Who may be able to join
- Symptoms suggestive of CAD, according to the opinion of the site registry clinician
- Receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD
- Age >= 18 years
- Willing and able to provide written informed consent
Who cannot join
- History of myocardial infarction (MI)
- Current MI or acute coronary syndrome
- Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
- Known/documented CAD
- Diabetes Mellitus
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Bells Medical Clinic
Bells, Texas, 75414
Family Care Clinic
Bonham, Texas, 75418
Warner Family Practice
Chandler, Arizona, 85224
Aldrich Internal Medicine
Dallas, Texas, 75218
Dayton Internal Medicine
Dayton, Ohio, 45402
TIMA Wellness
Greensboro, North Carolina, 27405
Synergy Health
Hiawassee, Georgia, 30546
Texas Familicare
Hurst, Texas, 76054
Paul McLaughlin, MD - Family Practice
Mount Sterling, Kentucky, 40353
Doctors for Health
Omaha, Nebraska, 68130
KD Health and Wellness Center
Simmesport, Louisiana, 71369
John's Creek Primary Care
Suwanee, Georgia, 30024
Northside Medical Center
Youngstown, Ohio, 44505
About this study
Official title: The PRESET Registry: A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Real World Clinical Care Settings
The PRESET Registry--A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (Age/Sex/Gene Expression score - ASGES) in Real World Clinical Care Settings (PRESET)--was designed as an observational, post-market, real-world registry to evaluate patterns of care, including referrals to a cardiologist, cardiac stress testing, CT angiography, within the first month after Corus CAD (ASGES) testing.
Read the detailed description
The prospective PRESET Registry (NCT01677156) enrolled stable, nonacute adult patients presenting with typical or atypical symptoms suggestive of obstructive coronary artery disease from 21 US primary care practices from August 2012 to August 2014. Demographics, clinical characteristics, and Corus CAD (Age/Sex/Gene Expression score - ASGES) results (predefined as low [ASGES <15] or elevated [ASGES >15]) were collected, as were referrals to Cardiology or further functional/anatomic cardiac testing after Corus CAD (Age/Sex/Gene Expression score - ASGES) testing. Patients were followed for 1 year post ASGES testing.
- Conditions
- Chest Pain, Coronary Artery Disease, Cardiovascular Diseases, Coronary Heart Disease, Angina Pectoris, CAD
- Being tested
- CORUS CAD (ASGES)
- Keywords
- ASGES, Corus CAD, Age/Sex/Gene Expression Score, Gene Expression, GES, CAD, CVD, CHD, Precision Medicine, Clinical Utility, Registry, Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Disease, Coronary Heart Disease, PRESET
- Medical subject headings
- Chest Pain, Coronary Artery Disease, Cardiovascular Diseases, Coronary Disease, Angina Pectoris
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 |
|---|---|---|
| Receiving Corus CAD (ASGES) | Patients receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD Receives: Diagnostic Test: CORUS CAD (ASGES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe referral patterns for cardiac care and testing within 1 month after gene expression testing.
Measured: 1 month
Secondary outcomes (1)
To describe follow up events (eg., diagnoses, non-cardiac testing, medication use, MACE) at 12 months follow up within ASGES (age, sex,gene expression score) test strata.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 713 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Zapien, MS, Study director, CardioDx, Inc.Mark Monane, MD, Principal investigator, CardioDx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677156
- Sponsor's protocol ID
- CDX_000015
- Other IDs
- PRESET
- Acronym
- PRESET
- Status last verified
- Jan 2019
- First submitted
- 29 Aug 2012
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ladapo JA, Budoff M, Sharp D, Zapien M, Huang L, Maniet B, Herman L, Monane M. Clinical Utility of a Precision Medicine Test Evaluating Outpatients with Suspected Obstructive Coronary Artery Disease. Am J Med. 2017 Apr;130(4):482.e11-482.e17. doi: 10.1016/j.amjmed.2016.11.021. Epub 2016 Dec 16.
PubMed 27993573Ladapo JA, Budoff MJ, Sharp D, Kuo JZ, Huang L, Maniet B, Herman L, Monane M. Utility of a Precision Medicine Test in Elderly Adults with Symptoms Suggestive of Coronary Artery Disease. J Am Geriatr Soc. 2018 Feb;66(2):309-315. doi: 10.1111/jgs.15215. Epub 2017 Dec 6.
PubMed 29210056
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
- The PRESET Registry: A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Real World Clinical Care Settings
- ClinicalTrials.gov ID
- NCT01677156
- Acronym / sponsor ID
- PRESET / CDX_000015
- Conditions
- Chest Pain, Coronary Artery Disease, Cardiovascular Diseases, Coronary Heart Disease, Angina Pectoris, CAD
- Keywords
- ASGES, Corus CAD, Age/Sex/Gene Expression Score, Gene Expression, GES, CAD, CVD, CHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 713 participants (actual)
- Lead sponsor
- CardioDxIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 31 Aug 2012 (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 PRESET Registry--A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (Age/Sex/Gene Expression score - ASGES) in Real World Clinical Care Settings (PRESET)--was designed as an observational, post-market, real-world registry to evaluate patterns of care, including referrals to a cardiologist, cardiac stress testing, CT angiography, within the first month after Corus CAD (ASGES) testing.
Detailed description
The prospective PRESET Registry (NCT01677156) enrolled stable, nonacute adult patients presenting with typical or atypical symptoms suggestive of obstructive coronary artery disease from 21 US primary care practices from August 2012 to August 2014. Demographics, clinical characteristics, and Corus CAD (Age/Sex/Gene Expression score - ASGES) results (predefined as low [ASGES <15] or elevated [ASGES >15]) were collected, as were referrals to Cardiology or further functional/anatomic cardiac testing after Corus CAD (Age/Sex/Gene Expression score - ASGES) testing. Patients were followed for 1 year post ASGES testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiving Corus CAD (ASGES) | – | Diagnostic Test: CORUS CAD (ASGES)Patients receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to their primary clinician's office with chest pain suggestive of obstructive coronary artery disease.
Key inclusion criteria (4 listed)
- Symptoms suggestive of CAD, according to the opinion of the site registry clinician
- Receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD
- Age >= 18 years
- Willing and able to provide written informed consent
Key exclusion criteria (5 listed)
- History of myocardial infarction (MI)
- Current MI or acute coronary syndrome
- Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
- Known/documented CAD
- Diabetes Mellitus
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 | Receiving Corus CAD (ASGES) |
Primary outcome
To describe referral patterns for cardiac care and testing within 1 month after gene expression testing.
Time frame: 1 month
1 secondary outcome
To describe follow up events (eg., diagnoses, non-cardiac testing, medication use, MACE) at 12 months follow up within ASGES (age, sex,gene expression score) test strata.
Time frame: 12 months
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.
- Background: PubMed 27993573Ladapo JA, Budoff M, Sharp D, Zapien M, Huang L, Maniet B, Herman L, Monane M. Clinical Utility of a Precision Medicine Test Evaluating Outpatients with Suspected Obstructive Coronary Artery Disease. Am J Med. 2017 Apr;130(4):482.e11-482.e17. doi: 10.1016/j.amjmed.2016.11.021. Epub 2016 Dec 16.
- Derived from this study: PubMed 29210056Ladapo JA, Budoff MJ, Sharp D, Kuo JZ, Huang L, Maniet B, Herman L, Monane M. Utility of a Precision Medicine Test in Elderly Adults with Symptoms Suggestive of Coronary Artery Disease. J Am Geriatr Soc. 2018 Feb;66(2):309-315. doi: 10.1111/jgs.15215. Epub 2017 Dec 6.
- Am J Med. 2017 Apr;130(4):482.e11-482.e17. doi: 10.1016/j.amjmed.2016.11.021. Epub 2016 Dec 16.Link provided by the sponsor.
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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.
Michael Zapien, MS study director
CardioDx, Inc.
Mark Monane, MD principal investigator
CardioDx, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain and Coronary Artery Disease, run by CardioDx at 13 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 4 inclusion and 5 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 13 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?
To describe referral patterns for cardiac care and testing within 1 month after gene expression testing. (time frame: 1 month). 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 NCT01677156, which also lists 2 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.