Atherosclerotic Cardiovascular DiseaseNCT03911284
The Learning Registry
An observational study of Atherosclerotic Cardiovascular Disease, run by Duke University at 1 site in United States.
Trial summary
The Learning Registry is a retrospective, exempt study. Researchers form the Duke Clinical Research Institute (DCRI) will utilize de-identified data managed by Cerner for population health analytics as part of a ongoing registry of patients with atherosclerotic cardiovascular disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 31 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with atherosclerotic cardiovascular disease
Who may be able to join
- Adults 18 and older For the overall ASCVD population, diagnose codes for cardiopulmonary disease, including disease of the pulmonary circulation, cardiac disease, and vascular disease will be used to identify the population to be de-identified. At MU, this will include patients back to 2012, and at Seton this will include patients back to 2014, which reflect dates of data availability at each health system. For both institutions, data collection for patients identified will stop at the end of 2019.
- For the chart review population, patients with hospitalization for cerebrovascular disease (e.g. stroke/TIA), coronary heart disease (i.e. myocardial infarction), and peripheral vascular disease (e.g. limb ischemia) will be eligible.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Learning Registry Creating the Learning Healthcare Platform of the Future: High Risk ASCVD Registry for Longitudinal Follow Up
The Learning Registry is a retrospective, exempt study. Researchers form the Duke Clinical Research Institute (DCRI) will utilize de-identified data managed by Cerner for population health analytics as part of a ongoing registry of patients with atherosclerotic cardiovascular disease.
Cerner is an electronic health record company utilized by a large number of health systems in the United States. As part of their services to the health systems that they work with, they have created platform for population health management called HealtheIntent. HealtheIntent uses individual data from patients at a health system collected through the EMR as well as other data streams in the health system (i.e. cost data), aggregates the data, and stores it on an Amazon Web Services cloud, accessible to both Cerner and the health systems, to perform large scale population health analytics. These data may be linked as well by Cerner to the National Death Index or other data sources depending on the individual relationship with the sites.
For this retrospective study, the Study Start Date is the date contracts were executed; Primary Completion Date is the date the final dataset is available for analysis and manuscript development; Study Completion Date is the date the study is completed. Enrollment is the number of patient charts reviewed.
Read the detailed description
DCRI will utilize data on patients with ASCVD from the Cerner's health systems who have agreed to participate in the Learning Registry. Cerner will de-identify the data and place it into a cloud-based server hosted by Amazon Web Services that is password-protected and accessible only to DCRI researchers.
The research goals for the Learning Registry are,
- Evaluate treatment patterns and gaps in care for patients with atherosclerotic cardiovascular disease. Across adults with ASCVD, treatment patterns for those groups will be evaluated, including aspirin, beta blockers, ace inhibitors, P2Y12 inhibitors, statins, and other antithrombotics. Factors associated with appropriate therapy use will be assessed, including patient level factors (age, race, sex, insurance status), clinical factors (type of ASCVD, comorbidities including kidney disease, atrial fibrillation, hypertension, diabetes, duration since last event), and system level factors (type of provider seen, frequency of contact with the healthcare system). Stratified analyses will include, but is not limited to, adults with PAD and adults who would have been eligible for the COMPASS trial.
- Estimate the attributable risk of modifiable risk factors on recurrent cardiovascular events in adults with established ASCVD.
Patients who present with myocardial infarction, unstable angina, stroke, and TIA will be identified. Those who have been previously seen in the outpatient setting will be evaluated for the presence of pre-existing cardiovascular disease to identify those with CVD prior to their event. Risk factor control prior to the event will be assessed. The amount of disease potentially preventable by risk factor control, as well as utilization of novel secondary preventive therapies including rivaroxaban will be evaluated.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Keywords
- ASCVD
- Medical subject headings
- Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization of guideline-directed medical therapy in adults with ASCVD
PERCENTAGE OF ELIGIBLE ADULTS ON GUIDELINE-RECOMMENDED SECONDARY PREVENTION THERAPY
Measured: September 2018-March 2020
Utilization of guideline-directed medical therapy in adults with ASCVD
PERCENTAGE OF ADULTS MEETING BLOOD PRESSURE GOALS
Measured: September 2018-March 2020
Utilization of guideline-directed medical therapy in adults with ASCVD
PERCENTAGE OF ADULTS ON STATIN THERAPY
Measured: September 2018- March 2020
Utilization of guideline-directed medical therapy in adults with ASCVD
PERCENTAGE OF ADULTS MEETING LDL-C GOALS
Measured: September 2018-March2020
Secondary outcomes (4)
Accuracy of EHR data to identify cardiovascular events and comorbidities.
WE WILL ASSESS THE POSITIVE PREDICTIVE VALUE OF EHR-BASED ALGORITHMS TO IDENTIFY STROKE
Measured: May 2019-March 2020
Accuracy of EHR data to identify cardiovascular events and comorbidities.
WE WILL ASSESS THE POSITIVE PREDICTIVE VALUE OF EHR-BASED ALGORITHMS TO IDENTIFY TRANSIENT ISCHEMIC ATTACK
Measured: May 2019-March 2020
Accuracy of EHR data to identify cardiovascular events and comorbidities.
WE WILL ASSESS THE POSITIVE PREDICTIVE VALUE OF EHR-BASED ALGORITHMS TO IDENTIFY MYOCARDIAL INFARCTION
Measured: May 2019-March 2020
Accuracy of EHR data to identify cardiovascular events and comorbidities.
WE WILL ASSESS THE POSITIVE PREDICTIVE VALUE OF EHR-BASED ALGORITHMS TO IDENTIFY UNSTABLE ANGINA
Measured: May 2019-March 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 Sep 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Nishant Shah, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911284
- Sponsor's protocol ID
- Pro00094697
- Status last verified
- Dec 2022
- First submitted
- 29 Aug 2018
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Learning Registry Creating the Learning Healthcare Platform of the Future: High Risk ASCVD Registry for Longitudinal Follow Up
- ClinicalTrials.gov ID
- NCT03911284
- Acronym / sponsor ID
- Pro00094697
- Conditions
- Atherosclerotic Cardiovascular Disease
- Keywords
- ASCVD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Apr 2019 (actual)
- 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 Learning Registry is a retrospective, exempt study. Researchers form the Duke Clinical Research Institute (DCRI) will utilize de-identified data managed by Cerner for population health analytics as part of a ongoing registry of patients with atherosclerotic cardiovascular disease.
Cerner is an electronic health record company utilized by a large number of health systems in the United States. As part of their services to the health systems that they work with, they have created platform for population health management called HealtheIntent. HealtheIntent uses individual data from patients at a health system collected through the EMR as well as other data streams in the health system (i.e. cost data), aggregates the data, and stores it on an Amazon Web Services cloud, accessible to both Cerner and the health systems, to perform large scale population health analytics. These data may be linked as well by Cerner to the National Death Index or other data sources depending on the individual relationship with the sites.
For this retrospective study, the Study Start Date is the date contracts were executed; Primary Completion Date is the date the final dataset is available for analysis and manuscript development; Study Completion Date is the date the study is completed. Enrollment is the number of patient charts reviewed.
Detailed description
DCRI will utilize data on patients with ASCVD from the Cerner's health systems who have agreed to participate in the Learning Registry. Cerner will de-identify the data and place it into a cloud-based server hosted by Amazon Web Services that is password-protected and accessible only to DCRI researchers.
The research goals for the Learning Registry are,
- Evaluate treatment patterns and gaps in care for patients with atherosclerotic cardiovascular disease. Across adults with ASCVD, treatment patterns for those groups will be evaluated, including aspirin, beta blockers, ace inhibitors, P2Y12 inhibitors, statins, and other antithrombotics. Factors associated with appropriate therapy use will be assessed, including patient level factors (age, race, sex, insurance status), clinical factors (type of ASCVD, comorbidities including kidney disease, atrial fibrillation, hypertension, diabetes, duration since last event), and system level factors (type of provider seen, frequency of contact with the healthcare system). Stratified analyses will include, but is not limited to, adults with PAD and adults who would have been eligible for the COMPASS trial.
- Estimate the attributable risk of modifiable risk factors on recurrent cardiovascular events in adults with established ASCVD.
Patients who present with myocardial infarction, unstable angina, stroke, and TIA will be identified. Those who have been previously seen in the outpatient setting will be evaluated for the presence of pre-existing cardiovascular disease to identify those with CVD prior to their event. Risk factor control prior to the event will be assessed. The amount of disease potentially preventable by risk factor control, as well as utilization of novel secondary preventive therapies including rivaroxaban will be evaluated.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with atherosclerotic cardiovascular disease
Key inclusion criteria (2 listed)
- Adults 18 and older For the overall ASCVD population, diagnose codes for cardiopulmonary disease, including disease of the pulmonary circulation, cardiac disease, and vascular disease will be used to identify the population to be de-identified. At MU, this will include patients back to 2012, and at Seton this will include patients back to 2014, which reflect dates of data availability at each health system. For both institutions, data collection for patients identified will stop at the end of 2019.
- For the chart review population, patients with hospitalization for cerebrovascular disease (e.g. stroke/TIA), coronary heart disease (i.e. myocardial infarction), and peripheral vascular disease (e.g. limb ischemia) will be eligible.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Utilization of guideline-directed medical therapy in adults with ASCVD
Time frame: September 2018-March 2020
PERCENTAGE OF ELIGIBLE ADULTS ON GUIDELINE-RECOMMENDED SECONDARY PREVENTION THERAPY
Utilization of guideline-directed medical therapy in adults with ASCVD
Time frame: September 2018-March 2020
PERCENTAGE OF ADULTS MEETING BLOOD PRESSURE GOALS
Utilization of guideline-directed medical therapy in adults with ASCVD
Time frame: September 2018- March 2020
PERCENTAGE OF ADULTS ON STATIN THERAPY
Utilization of guideline-directed medical therapy in adults with ASCVD
Time frame: September 2018-March2020
PERCENTAGE OF ADULTS MEETING LDL-C GOALS
4 secondary outcomes
Accuracy of EHR data to identify cardiovascular events and comorbidities.
Time frame: May 2019-March 2020
Accuracy of EHR data to identify cardiovascular events and comorbidities.
Time frame: May 2019-March 2020
Accuracy of EHR data to identify cardiovascular events and comorbidities.
Time frame: May 2019-March 2020
Accuracy of EHR data to identify cardiovascular events and comorbidities.
Time frame: May 2019-March 2020
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 20 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Nishant Shah, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Disease, run by Duke University at 1 site 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 2 inclusion and 1 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 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Utilization of guideline-directed medical therapy in adults with ASCVD (time frame: September 2018-March 2020). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2023.