ASCVDNCT07868809
Coronary Artery Calcium (CAC) Testing in Primary Care
A study testing Our Practice Advisory (OPA) in people with ASCVD and ASCVD Management, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The goal of this study is to improve how primary care providers identify and manage patients at risk for heart disease. One tool that can help with this is a coronary artery calcium (CAC) test, which looks for calcium buildup in the heart's arteries and can help estimate a person's risk of future heart problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ASCVD, ASCVD Management, Coronary Artery Calcium
- What is being tested?
- Our Practice Advisory (OPA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary care provider (physician or nurse practitioner) at Weill Cornell Internal Medicine Associates (WCIMA).
- Participated in clinical practice during the Our Practice Advisory (OPA) implementation period.
Who cannot join
- Not a primary care provider (physician or nurse practitioner) at WCIMA.
- Did not participate in clinical practice during the Our Practice Advisory (OPA) implementation period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Weill Cornell Medicine
New York, New York, 10021
Madeline R Sterling, MD, MPH, MS, FAHA, 646-962-5029, mrs9012@med.cornell.edu
Madeline R Sterling, MD, MPH, MS, FAHA
About this study
Official title: Identifying Predictors of Coronary Artery Calcium (CAC) Testing in Primary Care and Implementing a Novel-intervention to Improve Uptake
The goal of this study is to improve how primary care providers identify and manage patients at risk for heart disease. One tool that can help with this is a coronary artery calcium (CAC) test, which looks for calcium buildup in the heart's arteries and can help estimate a person's risk of future heart problems.
The main questions this study aims to answer are:
Read more
Will a new electronic health record (EHR) alert that provides guidance on when to consider a CAC test be feasible and acceptable to primary care providers? Does the alert change how often providers order CAC tests, start or change the dose of cholesterol-lowering medications, and refer patients to cardiology?
In this study, a new EHR alert will be implemented as part of routine clinical practice for primary care providers at Weill Cornell Internal Medicine Associates (WCIMA). The alert will provide guidance on considering a CAC test, cholesterol-lowering medication, or referral to cardiology for eligible patients. Researchers will compare clinical care before and after the alert is implemented. They will look at how often CAC tests are ordered and completed, how often cholesterol-lowering medications are started or their doses are changed, and how often patients are referred to cardiology. After the implementation period, primary care providers will also be asked to complete a brief survey and participate in an interview about the alert.
Read the detailed description
Researchers will conduct an implementation pilot using a pre- and post-implementation design to evaluate the impact of an electronic health record (EHR)-based Practice Advisory (OPA) on clinical and implementation outcomes. The study will take place at Weill Cornell Internal Medicine Associates (WCIMA), a large academic, hospital-based primary care practice at Weill Cornell Medicine and NewYork-Presbyterian Hospital in New York, NY. The study will include EHR data from adults without known cardiovascular disease (CVD) who have borderline to intermediate PREVENT-estimated 10-year ASCVD risk and are between 30 and 79 years of age. These patients will be seen by primary care providers at WCIMA during an 8-month implementation period in 2027. The OPA will be implemented in the EHR for primary care physicians at WCIMA as part of routine clinical practice. The OPA will be triggered for eligible patients and will provide guidance on three potential actions: ordering a coronary artery calcium (CAC) test, initiating or changing the dose of lipid-lowering therapy, and referring the patient to cardiology. Researchers will evaluate the impact of the OPA by comparing outcomes before and after implementation. The primary outcome will be the proportion of eligible patient encounters resulting in a CAC test order. Secondary outcomes will include completed CAC testing, initiation or dose titration of lipid-lowering therapy, and referrals to cardiology. The implementation of the OPA will also be evaluated using a modified RE-AIM framework, including Reach, Effectiveness, Adoption, Implementation, and Maintenance. Following the 8-month implementation period, primary care clinicians at WCIMA will be invited to complete a brief survey and participate in a semi-structured interview. The survey will assess the acceptability and feasibility of the OPA using the validated Acceptability of Implementation Measure (AIM) and Feasibility of Implementation Measure (FIM). Interviews will explore clinicians' perspectives on whether the OPA affected clinical decision-making, CAC ordering, lipid-lowering therapy prescribing, cardiology referrals, and workflow. Interviews will be audio-recorded, transcribed, and analyzed using thematic analysis guided by the RE-AIM framework.
- Conditions
- ASCVD, ASCVD Management, Coronary Artery Calcium, Hyperlipidemia
- Being tested
- Our Practice Advisory (OPA)
- Keywords
- Coronary Artery Calcium Testing, Primary Care, Lipid Lowering Therapy, ASCVD, Intermediate Risk ASCVD
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Our Practice Advisory (OPA)Other
This OPA, which will be within the EHR, will be visible when a patient has borderline or intermediate PREVENT-estimated 10-year ASCVD risk and lipid-lowering treatment decisions remain uncertain. The proposed actions will be:
Discuss the patient's cholesterol and elevated cardiovascular risk. Guide the clinician on ordering a CAC test. Consider referral to a cardiologist or subspecialist. Consider initiation or dose titration of lipid-lowering therapy.
The goal is to understand the impact of the OPA on primary care clinicians' clinical decision-making surrounding patients with borderline or intermediate ASCVD risk.
| Study group | Role | What they receive |
|---|---|---|
| All primary care providers at Weill Cornell Internal Medicine Associates (WCIMA) | Experimental | For 8 months, an Our Practice Advisory (OPA) will be visible to primary care providers within Epic. The OPA will be activated for eligible adults without established CVD who have borderline or intermediate PREVENT-estimated 10-year ASCVD risk and for whom lipid-lowering treatment decisions remain uncertain. The proposed actions will be to order a CAC test, consider referral to cardiology, and initiate or intensify lipid-lowering therapy, including dose titration when appropriate. Receives: Other: Our Practice Advisory (OPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure
Feasibility will be assessed with a validated, 4-item, Feasibility of Intervention Measure. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). The score is calculated as the mean. The scale for this measure ranges from 4-20 with higher scores indicating greater perceived feasibility of the intervention.
Measured: Post-implementation, within 4 months following completion of the 8-month OPA implementation period
Acceptability of Intervention
Acceptability will be assessed through the 4-item, validated, Acceptability of Intervention Measure. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). The score is calculated as the mean. The scale for this measure ranges from 4-20 with higher scores indicating greater perceived acceptability of the intervention.
Measured: Post-implementation, within 4 months following completion of the 8-month OPA implementation period
Change in Number of Coronary Artery Calcium (CAC) Tests Ordered
Change in the number of CAC tests ordered among eligible patients between the pre-OPA implementation and post-OPA implementation periods.
Measured: Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months
Secondary outcomes (4)
Change in Number of Completed CAC Tests
Change in the number of CAC tests completed among eligible patients between the pre-OPA implementation and post-OPA implementation periods.
Measured: Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months
Change in Number of Lipid-Lowering Therapy (LLT) Initiations
Change in the number of eligible patients for whom lipid-lowering therapy is initiated between the pre-OPA implementation and post-OPA implementation periods.
Measured: Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months
Change in Lipid-Lowering Therapy (LLT) titration
Change in the number of eligible patients for whom lipid-lowering therapy is titrated between the pre-OPA implementation and post-OPA implementation periods, including an increase in dosage, decrease in dosage, or change in LLT type.
Measured: Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months
Change in Number of Referrals to Cardiology or Subspecialty
Change in the number of referrals to cardiology or subspecialty care among eligible patients between the pre-OPA implementation and post-OPA implementation periods.
Measured: Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Feb 2027 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASCVDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Practice-wide implementation of an EHR-based Practice Advisory (OPA), with outcomes evaluated using a pre- and post-implementation design.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Madeline R Sterling, MD, MPH, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868809
- Sponsor's protocol ID
- 26-01029730
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 15 Oct 2026
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Predictors of Coronary Artery Calcium (CAC) Testing in Primary Care and Implementing a Novel-intervention to Improve Uptake
- ClinicalTrials.gov ID
- NCT07868809
- Acronym / sponsor ID
- 26-01029730
- Conditions
- ASCVD, ASCVD Management, Coronary Artery Calcium, Hyperlipidemia
- Keywords
- Coronary Artery Calcium Testing, Primary Care, Lipid Lowering Therapy, ASCVD, Intermediate Risk ASCVD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 9 Oct 2026 (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 goal of this study is to improve how primary care providers identify and manage patients at risk for heart disease. One tool that can help with this is a coronary artery calcium (CAC) test, which looks for calcium buildup in the heart's arteries and can help estimate a person's risk of future heart problems.
The main questions this study aims to answer are:
Will a new electronic health record (EHR) alert that provides guidance on when to consider a CAC test be feasible and acceptable to primary care providers? Does the alert change how often providers order CAC tests, start or change the dose of cholesterol-lowering medications, and refer patients to cardiology?
In this study, a new EHR alert will be implemented as part of routine clinical practice for primary care providers at Weill Cornell Internal Medicine Associates (WCIMA). The alert will provide guidance on considering a CAC test, cholesterol-lowering medication, or referral to cardiology for eligible patients. Researchers will compare clinical care before and after the alert is implemented. They will look at how often CAC tests are ordered and completed, how often cholesterol-lowering medications are started or their doses are changed, and how often patients are referred to cardiology. After the implementation period, primary care providers will also be asked to complete a brief survey and participate in an interview about the alert.
Detailed description
Researchers will conduct an implementation pilot using a pre- and post-implementation design to evaluate the impact of an electronic health record (EHR)-based Practice Advisory (OPA) on clinical and implementation outcomes. The study will take place at Weill Cornell Internal Medicine Associates (WCIMA), a large academic, hospital-based primary care practice at Weill Cornell Medicine and NewYork-Presbyterian Hospital in New York, NY. The study will include EHR data from adults without known cardiovascular disease (CVD) who have borderline to intermediate PREVENT-estimated 10-year ASCVD risk and are between 30 and 79 years of age. These patients will be seen by primary care providers at WCIMA during an 8-month implementation period in 2027. The OPA will be implemented in the EHR for primary care physicians at WCIMA as part of routine clinical practice. The OPA will be triggered for eligible patients and will provide guidance on three potential actions: ordering a coronary artery calcium (CAC) test, initiating or changing the dose of lipid-lowering therapy, and referring the patient to cardiology. Researchers will evaluate the impact of the OPA by comparing outcomes before and after implementation. The primary outcome will be the proportion of eligible patient encounters resulting in a CAC test order. Secondary outcomes will include completed CAC testing, initiation or dose titration of lipid-lowering therapy, and referrals to cardiology. The implementation of the OPA will also be evaluated using a modified RE-AIM framework, including Reach, Effectiveness, Adoption, Implementation, and Maintenance. Following the 8-month implementation period, primary care clinicians at WCIMA will be invited to complete a brief survey and participate in a semi-structured interview. The survey will assess the acceptability and feasibility of the OPA using the validated Acceptability of Implementation Measure (AIM) and Feasibility of Implementation Measure (FIM). Interviews will explore clinicians' perspectives on whether the OPA affected clinical decision-making, CAC ordering, lipid-lowering therapy prescribing, cardiology referrals, and workflow. Interviews will be audio-recorded, transcribed, and analyzed using thematic analysis guided by the RE-AIM framework.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Practice-wide implementation of an EHR-based Practice Advisory (OPA), with outcomes evaluated using a pre- and post-implementation design.
| Arm | Type | Receives |
|---|---|---|
| All primary care providers at Weill Cornell Internal Medicine Associates (WCIMA) | Experimental | Other: Our Practice Advisory (OPA)For 8 months, an Our Practice Advisory (OPA) will be visible to primary care providers within Epic. The OPA will be activated for eligible adults without established CVD who have borderline or intermediate PREVENT-estimated 10-year ASCVD risk and for whom lipid-lowering treatment decisions remain uncertain. The proposed actions will be to order a CAC test, consider referral to cardiology, and initiate or intensify lipid-lowering therapy, including dose titration when appropriate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary care provider (physician or nurse practitioner) at Weill Cornell Internal Medicine Associates (WCIMA).
- Participated in clinical practice during the Our Practice Advisory (OPA) implementation period.
Key exclusion criteria (2 listed)
- Not a primary care provider (physician or nurse practitioner) at WCIMA.
- Did not participate in clinical practice during the Our Practice Advisory (OPA) implementation period.
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 |
|---|---|---|
| Our Practice Advisory (OPA)This OPA, which will be within the EHR, will be visible when a patient has borderline or intermediate PREVENT-estimated 10-year ASCVD risk and lipid-lowering treatment decisions remain uncertain. The proposed actions will be: Discuss the patient's cholesterol and elevated cardiovascular risk. Guide the clinician on ordering a CAC test. Consider referral to a cardiologist or subspecialist. Consider initiation or dose titration of lipid-lowering therapy. The goal is to understand the impact of the OPA on primary care clinicians' clinical decision-making surrounding patients with borderline or intermediate ASCVD risk. | Other | All primary care providers at Weill Cornell Internal Medicine Associates (WCIMA) |
Primary outcome
Feasibility of Intervention Measure
Time frame: Post-implementation, within 4 months following completion of the 8-month OPA implementation period
Feasibility will be assessed with a validated, 4-item, Feasibility of Intervention Measure. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). The score is calculated as the mean. The scale for this measure ranges from 4-20 with higher scores indicating greater perceived feasibility of the intervention.
Acceptability of Intervention
Time frame: Post-implementation, within 4 months following completion of the 8-month OPA implementation period
Acceptability will be assessed through the 4-item, validated, Acceptability of Intervention Measure. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). The score is calculated as the mean. The scale for this measure ranges from 4-20 with higher scores indicating greater perceived acceptability of the intervention.
Change in Number of Coronary Artery Calcium (CAC) Tests Ordered
Time frame: Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months
Change in the number of CAC tests ordered among eligible patients between the pre-OPA implementation and post-OPA implementation periods.
4 secondary outcomes
Change in Number of Completed CAC Tests
Time frame: Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months
Change in Number of Lipid-Lowering Therapy (LLT) Initiations
Time frame: Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months
Change in Lipid-Lowering Therapy (LLT) titration
Time frame: Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months
Change in Number of Referrals to Cardiology or Subspecialty
Time frame: Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- 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.
Madeline R Sterling, MD, MPH principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Our Practice Advisory (OPA) in people with ASCVD and ASCVD Management, run by Weill Medical College of Cornell 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 2 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: opening soon, as of the sponsor's last update on 15 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeline R Sterling, MD, MPH (646-962-5029, mrs9012@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Measure (time frame: Post-implementation, within 4 months following completion of the 8-month OPA implementation period). The study lists 3 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 15 Oct 2026.