Cardiovascular Primary Prevention StrategyCorCalNCT03439267
Effectiveness of a Proactive Cardiovascular Primary Prevention Strategy, With or Without the Use of Coronary Calcium Screening, in Preventing Future Major Adverse Cardiac Events
A study testing Coronary Artery Calcium Screening and Statin Treatment and Standard Treatment in people with Cardiovascular Primary Prevention Strategy, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to test the effectiveness of a proactive cardiovascular primary prevention strategy, with or without the use of coronary calcium screening, compared to current standard care, in preventing future major adverse cardiac events (MACE), including all-cause death, non-fatal myocardial… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Primary Prevention Strategy
- What is being tested?
- Coronary Artery Calcium Screening and Statin Treatment and Standard Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,765 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2018to 6 Apr 2027
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subjects 50 to 80 years of age or female subjects 60 to 80 years of age, of any ethnic origin
- Ability to understand and provide agreement to study participation, which must be obtained prior to initiation of any study procedures
- No known history, as documented in the EHR, of coronary artery disease, cerebrovascular disease, peripheral vascular disease, or diabetes mellitus at enrollment
- Willing and able to provide access to their EHR until study end
- Willing and able to undergo a computed tomography (CT) coronary artery calcium screening test
- Current and/or past patients seen at Intermountain facilities and who have accessible EHR at the facility(ties) where they are seen.
Who cannot join
- Patients who have active on-going cancer or are on dialysis
- Any evidence of statin use prior to study participation
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
- Any evidence of a CAC test within the last 5 years prior to screening
- The Study Doctor(s) determine(s) that the subject is not eligible for participation in this research study
- The subject is non-English speaking, and therefore may be unable to fully understand the written and spoken instructions that may relate to the proper conduct of the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Medical Center and Intermountain Clinics
Murray, Utah, 84143
About this study
The primary objective of this study is to test the effectiveness of a proactive cardiovascular primary prevention strategy, with or without the use of coronary calcium screening, compared to current standard care, in preventing future major adverse cardiac events (MACE), including all-cause death, non-fatal myocardial infarction (MI), stroke, or any arterial revascularization among a moderate risk population with no current evidence of cardiovascular disease.
Read the detailed description
This is a randomized, open-label, pragmatic study designed to assess the effectiveness of coronary calcium screening. Patients who provide consent, and are eligible, will be randomized 1:1 to receive statin recommendation based on coronary calcium screening results or standard risk assessment results using the American Heart Association/American College of Cardiology (AHA/ACC)-recommended pooled cohort equation.
Management of all participants will be done through their primary care physicians/clinicians and their qualified delegates who will receive education and training from the Principal Investigator and/or his delegate about the two treatment strategies. The current National guidelines group will be managed following the AHA/ACC guidelines for statin initiation and follow-up. The coronary artery calcium (CAC) group will undergo coronary artery calcium screening and will receive a statin recommendation based on the proposed CAC cardiovascular (CV) risk algorithm. All subjects will be asked to complete the Intermountain Statin Adherence Questionnaire (ISAQ) at 3 months after recommendation (+ 60 days) and then annually thereafter (within +/- 60 days of the anniversary date of recommendation). All subjects will remain under the usual care of their primary care physicians and will be followed by the study team via their electronic health records (EHR) for approximately an average of 4 years following the subjects' anniversary date of recommendation, but until the target primary endpoint event rate is met. All enrolled subjects will be followed for outcomes and this will be completely done by electronic medical records query. Other than the time point to obtain agreement for study participation and to perform the CAC screening and/or lipid panel, there will be no other study-specific clinic visits required. Further, there will be no other treatments or procedures required for this study. After about the first 600 patients are enrolled, an interim meeting will occur to evaluate entry criteria and size to determine if any modifications to the protocol should occur.
- Being tested
- Coronary Artery Calcium Screening and Statin Treatment, Standard Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Artery Calcium Screening and Statin TreatmentCombination product
Will undergo coronary artery calcium screening and will receive statin treatment based on the cardiovascular risk algorithm.
Standard TreatmentOther
Patients will be managed following the AHA/ACC guidelines for statin initiation and follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Proactive Current National Guidelines Group | Active comparator | Standard Interventional Control Group. Will receive treatment recommendation according to the current National guidelines for statin initiation and follow-up. Receives: Other: Standard Treatment |
| Proactive CAC Group | Experimental | Investigational Interventional Group. Will undergo coronary artery calcium screening and will receive statin recommendation based on the cardiovascular risk algorithm. Receives: Combination Product: Coronary Artery Calcium Screening and Statin Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Composite of all-cause mortality, myocardial infarction, stroke, and revascularization (coronary, carotid, and peripheral).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start26 Mar 2018
- Primary completion6 Apr 2026
- Study completion6 Apr 2027 (estimated)
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 Cardiovascular Primary Prevention StrategyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,765 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph B Muhlestein, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439267
- Sponsor's protocol ID
- 1050633
- Acronym
- CorCal
- Status last verified
- Apr 2026
- First submitted
- 14 Feb 2018
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson JL, May HT, Winslow T, Le VT, Iverson L, Bair TL, Knowlton KU, Muhlestein JB. CorCal Outcomes: A randomized trial using the pooled cohort equation or coronary artery calcium to select statin therapy in primary prevention patients. Study design and baseline characteristics. Am Heart J. 2026 Sep;299:107473. doi: 10.1016/j.ahj.2026.107473. Epub 2026 May 7.
PubMed 42106092Muhlestein JB, Knowlton KU, Le VT, Lappe DL, May HT, Min DB, Johnson KM, Cripps ST, Schwab LH, Braun SB, Bair TL, Anderson JL. Coronary Artery Calcium Versus Pooled Cohort Equations Score for Primary Prevention Guidance: Randomized Feasibility Trial. JACC Cardiovasc Imaging. 2022 May;15(5):843-855. doi: 10.1016/j.jcmg.2021.11.006. Epub 2021 Dec 15.
PubMed 34922872
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Proactive Cardiovascular Primary Prevention Strategy, With or Without the Use of Coronary Calcium Screening, in Preventing Future Major Adverse Cardiac Events
- ClinicalTrials.gov ID
- NCT03439267
- Acronym / sponsor ID
- CorCal / 1050633
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,765 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 6 Apr 2027 (estimated)
- First posted
- 20 Feb 2018 (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 primary objective of this study is to test the effectiveness of a proactive cardiovascular primary prevention strategy, with or without the use of coronary calcium screening, compared to current standard care, in preventing future major adverse cardiac events (MACE), including all-cause death, non-fatal myocardial infarction (MI), stroke, or any arterial revascularization among a moderate risk population with no current evidence of cardiovascular disease.
Detailed description
This is a randomized, open-label, pragmatic study designed to assess the effectiveness of coronary calcium screening. Patients who provide consent, and are eligible, will be randomized 1:1 to receive statin recommendation based on coronary calcium screening results or standard risk assessment results using the American Heart Association/American College of Cardiology (AHA/ACC)-recommended pooled cohort equation.
Management of all participants will be done through their primary care physicians/clinicians and their qualified delegates who will receive education and training from the Principal Investigator and/or his delegate about the two treatment strategies. The current National guidelines group will be managed following the AHA/ACC guidelines for statin initiation and follow-up. The coronary artery calcium (CAC) group will undergo coronary artery calcium screening and will receive a statin recommendation based on the proposed CAC cardiovascular (CV) risk algorithm. All subjects will be asked to complete the Intermountain Statin Adherence Questionnaire (ISAQ) at 3 months after recommendation (+ 60 days) and then annually thereafter (within +/- 60 days of the anniversary date of recommendation). All subjects will remain under the usual care of their primary care physicians and will be followed by the study team via their electronic health records (EHR) for approximately an average of 4 years following the subjects' anniversary date of recommendation, but until the target primary endpoint event rate is met. All enrolled subjects will be followed for outcomes and this will be completely done by electronic medical records query. Other than the time point to obtain agreement for study participation and to perform the CAC screening and/or lipid panel, there will be no other study-specific clinic visits required. Further, there will be no other treatments or procedures required for this study. After about the first 600 patients are enrolled, an interim meeting will occur to evaluate entry criteria and size to determine if any modifications to the protocol should occur.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proactive Current National Guidelines Group | Active comparator | Other: Standard TreatmentStandard Interventional Control Group. Will receive treatment recommendation according to the current National guidelines for statin initiation and follow-up. |
| Proactive CAC Group | Experimental | Combination Product: Coronary Artery Calcium Screening and Statin TreatmentInvestigational Interventional Group. Will undergo coronary artery calcium screening and will receive statin recommendation based on the cardiovascular risk algorithm. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male subjects 50 to 80 years of age or female subjects 60 to 80 years of age, of any ethnic origin
- Ability to understand and provide agreement to study participation, which must be obtained prior to initiation of any study procedures
- No known history, as documented in the EHR, of coronary artery disease, cerebrovascular disease, peripheral vascular disease, or diabetes mellitus at enrollment
- Willing and able to provide access to their EHR until study end
- Willing and able to undergo a computed tomography (CT) coronary artery calcium screening test
Key exclusion criteria (6 listed)
- Patients who have active on-going cancer or are on dialysis
- Any evidence of statin use prior to study participation
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
- Any evidence of a CAC test within the last 5 years prior to screening
- The Study Doctor(s) determine(s) that the subject is not eligible for participation in this research study
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 |
|---|---|---|
| Coronary Artery Calcium Screening and Statin TreatmentWill undergo coronary artery calcium screening and will receive statin treatment based on the cardiovascular risk algorithm. | Combination product | Proactive CAC Group |
| Standard TreatmentPatients will be managed following the AHA/ACC guidelines for statin initiation and follow-up. | Other | Proactive Current National Guidelines Group |
Primary outcome
MACE
Time frame: 5 years
Composite of all-cause mortality, myocardial infarction, stroke, and revascularization (coronary, carotid, and peripheral).
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 14 Apr 2026.
- Derived from this study: PubMed 42106092Anderson JL, May HT, Winslow T, Le VT, Iverson L, Bair TL, Knowlton KU, Muhlestein JB. CorCal Outcomes: A randomized trial using the pooled cohort equation or coronary artery calcium to select statin therapy in primary prevention patients. Study design and baseline characteristics. Am Heart J. 2026 Sep;299:107473. doi: 10.1016/j.ahj.2026.107473. Epub 2026 May 7.
- Derived from this study: PubMed 34922872Muhlestein JB, Knowlton KU, Le VT, Lappe DL, May HT, Min DB, Johnson KM, Cripps ST, Schwab LH, Braun SB, Bair TL, Anderson JL. Coronary Artery Calcium Versus Pooled Cohort Equations Score for Primary Prevention Guidance: Randomized Feasibility Trial. JACC Cardiovasc Imaging. 2022 May;15(5):843-855. doi: 10.1016/j.jcmg.2021.11.006. Epub 2021 Dec 15.
- 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.
Joseph B Muhlestein, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Artery Calcium Screening and Statin Treatment and Standard Treatment in people with Cardiovascular Primary Prevention Strategy, run by Intermountain Health Care, Inc. 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 14 Apr 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?
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?
MACE (time frame: 5 years). 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 NCT03439267, 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 14 Apr 2026.