Coronary Calcium Screening + Statins for Cardiovascular Prevention

(CorCal Trial)

Overseen By Patti Spencer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Intermountain Health Care, Inc.

Must not be taking: Statins

Disqualifiers: Cancer, Dialysis, Other trials, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

5765 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used statins before joining the study.

What data supports the effectiveness of the treatment Coronary Artery Calcium Screening + Statins for Cardiovascular Prevention?

Statins are known to reduce the risk of heart problems by lowering cholesterol, but they may not reduce coronary calcium levels. However, people with no detectable coronary calcium have a much lower risk of heart disease, even if they are recommended for statin therapy. ^{1 2 3 4 5}

Is coronary calcium screening with statins safe for humans?

Statins are generally well tolerated and have been studied in many trials with hundreds of thousands of people. However, they can have side effects, mainly affecting muscles, liver, kidneys, and the nervous system. Coronary calcium screening helps identify those who might benefit most from statins, especially if they have muscle complaints. ^{2 4 5 6 7}

How does the statin treatment differ from other treatments for cardiovascular prevention?

This treatment is unique because it combines coronary calcium screening with statin therapy to better assess and personalize cardiovascular risk, potentially allowing some patients to avoid unnecessary statin use if their calcium score is zero, indicating a lower risk of heart disease. ^{1 4 8 9 10}

What is the purpose of this trial?

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.

Research Team

Joseph B Muhlestein, MD

Principal Investigator

Intermountain Medical Center

Eligibility Criteria

This trial is for men aged 50-80 and women aged 60-80 with no history of cardiovascular disease or diabetes, who haven't used statins or had a coronary calcium test in the last 5 years. Participants must be able to provide electronic health records and understand study procedures.

Inclusion Criteria

I have no history of heart, brain blood vessel, peripheral artery diseases, or diabetes.

Willing and able to provide access to their EHR until study end

Current and/or past patients seen at Intermountain facilities and who have accessible EHR at the facility(ties) where they are seen.

Exclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive statin recommendations based on coronary calcium screening results or standard risk assessment results

5 years

No study-specific clinic visits required

Follow-up

Participants are monitored for major adverse cardiac events through electronic health records

4 years

Treatment Details

Interventions

• Coronary Artery Calcium Screening
• Standard Treatment
• Statin Treatment

Trial Overview The study tests if proactive heart disease prevention strategies, including coronary artery calcium screening followed by statin treatment, can prevent major cardiac events better than standard care in people at moderate risk but without current heart disease.

Participant Groups

Group I: Proactive CAC Group Experimental Treatment 1 Intervention

Investigational Interventional Group. Will undergo coronary artery calcium screening and will receive statin recommendation based on the cardiovascular risk algorithm.

Group II: Proactive Current National Guidelines Group Active Control 1 Intervention

Standard Interventional Control Group. Will receive treatment recommendation according to the current National guidelines for statin initiation and follow-up.

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials

142

Recruited

1,965,000+

Findings from Research

Statins have been proven effective in improving lipid levels and significantly reducing the risk of atherosclerotic coronary artery disease (CAD), which leads to lower morbidity and mortality rates associated with CAD.

While statins are generally well tolerated, there are safety concerns regarding potential adverse effects on muscles, liver, kidneys, and the nervous system, with some risks being well-documented and others remaining speculative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statin safety: an overview and assessment of the data--2005. Bays, H.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Does statin therapy affect the progression of atherosclerosis measured by a coronary calcium score? [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Collective impact of conventional cardiovascular risk factors and coronary calcium score on clinical outcomes with or without statin therapy: The St Francis Heart Study. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Progression of coronary artery calcium and risk of first myocardial infarction in patients receiving cholesterol-lowering therapy. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Relation of Absence of Coronary Artery Calcium to Cardiovascular Disease Mortality Risk Among Individuals Meeting Criteria for Statin Therapy According to the 2018/2019 ACC/AHA Guidelines. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term statin therapy is associated with severe coronary artery calcification. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Statin safety: an overview and assessment of the data--2005. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Coronary artery calcium scoring in patients with statin associated muscle symptoms: Prescribing statins for those most likely to benefit. [2022]

8. England pubmed.ncbi.nlm.nih.gov

HOPE for Rational Statin Allocation for Primary Prevention: A Coronary Artery Calcium Picture Is Worth 1000 Words. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Statin therapy for primary prevention in men: What is the role for coronary artery calcium? [2023]

10. United States pubmed.ncbi.nlm.nih.gov

JCL roundtable: Coronary artery calcium scoring and other vascular imaging for risk assessment. [2020]