Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Proactive CAC Group | Experimental | Investigational Interventional Group. Will undergo coronary artery calcium screening and will receive statin recommendation based on the cardiovascular risk algorithm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Artery Calcium Screening and Statin Treatment | Combination Product | Will undergo coronary artery calcium screening and will receive statin treatment based on the cardiovascular risk algorithm. |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | Composite of all-cause mortality, myocardial infarction, stroke, and revascularization (coronary, carotid, and peripheral). | 5 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joseph B Muhlestein, MD | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center and Intermountain Clinics | Murray | Utah | 84143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42106092 | Derived | 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. | |
| 34922872 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard Treatment | Other | Patients will be managed following the AHA/ACC guidelines for statin initiation and follow-up. |
|
| Muhlestein 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. |