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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to prevent serious heart problems, such as heart attacks and strokes. It compares two approaches: one uses a special heart scan (coronary calcium screening) to determine if statins (medications that lower cholesterol) should be recommended, while the other follows current national health guidelines. Individuals with no history of heart disease or diabetes who are willing to undergo a heart scan might be suitable candidates. The study aims to determine if the heart scan approach prevents major heart issues more effectively than usual care. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve heart health strategies.

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 prior data suggests that coronary calcium screening and statin treatment are safe for cardiovascular prevention?

Research has shown that both coronary artery calcium (CAC) screening and statin treatments are safe and effective in preventing heart disease. CAC screening uses a CT scan to detect calcium in the arteries, helping to predict heart disease risk. One study found that 98% of patients who underwent this screening were alive five years later, compared to 95% of those who did not, suggesting the screening is safe and can identify those at higher risk.

Statins, medications used to lower cholesterol, are generally safe and effective in preventing heart attacks and strokes. Studies indicate that people taking statins experience fewer heart problems than those who do not. Statins have been used for a long time for various conditions, supporting their safety record. However, like any medication, they can have side effects, so discussing these with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a proactive approach to cardiovascular prevention by combining coronary artery calcium (CAC) screening with statin recommendations tailored to individual risk. Unlike traditional methods that rely solely on national guidelines, this approach personalizes statin use based on actual calcium deposits in the arteries, potentially improving prevention strategies. This method might offer a more accurate assessment of cardiovascular risk, leading to better-targeted treatments and outcomes for patients.

What evidence suggests that this trial's treatments could be effective for preventing major adverse cardiac events?

Research has shown that using coronary artery calcium (CAC) scoring to guide statin treatment can help prevent heart problems. In this trial, participants in the Proactive CAC Group will undergo CAC screening and receive statin recommendations based on a cardiovascular risk algorithm. One study found that administering statins to individuals with a CAC score above zero significantly improved health and extended life expectancy. Another study found that increasing statin use in patients with any heart disease reduced major heart-related issues by 5%. CAC scoring also identifies which patients benefit most from statins, enhancing heart disease prevention. Overall, using CAC scoring with statins is a promising approach to lowering the risk of serious heart problems. ^{6 7 8 9 10}

Who Is on the Research Team?

Joseph B Muhlestein, MD

Principal Investigator

Intermountain Medical Center

Are You a Good Fit for This Trial?

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

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.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4156513/

Using the Coronary Artery Calcium Score to Guide Statin ... Measuring CAC and targeting statin treatment to the 2,500 women with CAC>0 would provide 45% of the benefit (+501 life-years), but CAC measurement would cost ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936878X25003109

Interaction Between Statin Use, Coronary Artery Disease ... 10% increase in statin use reduced the risk of MACE in patients with any CAD (aHR: 0.95 [95% CI: 0.92-0.99]; P = 0.006); however, this was not ...

3. jacc.org jacc.org/doi/10.1016/j.jacc.2018.09.051

Impact of Statins on Cardiovascular Outcomes Following ... The presence and severity of CAC identified patients most likely to benefit from statins for the primary prevention of cardiovascular diseases.

4. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2781973

Coronary Artery Calcium Scoring to Guide Statin Therapy ... The use of coronary artery calcium scoring was associated with significant improvements in the reclassification and discrimination of atherosclerotic ...

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.041543?doi=10.1161/JAHA.124.041543

Cost‐Effectiveness of Coronary Artery Calcium Scoring for ... Broadening the use of high‐intensity statins and low‐dose aspirin in patients aged 45 to 84 years with diabetes can be considered cost‐effective ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10443952/

Coronary calcium by computed tomography and outcomes 98% of the patients who underwent computed tomography (CT) calcium scoring surviving at 5 years as opposed to only 95% of those who did not undergo CT calcium ...

7. jacc.org jacc.org/doi/10.1016/j.jacadv.2023.100664

Coronary Artery Calcium Score as a Graded Decision Tool A patient with a CAC score of >300 has comparable ASCVD risk to that of a post myocardial infarction survivor or someone who had undergone ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1936878X25000373

Guideline-Directed Application of Coronary Artery Calcium ... The coronary artery calcium (CAC) score has been consistently shown to predict atherosclerotic cardiovascular disease (ASCVD) outcomes beyond traditional risk ...

9. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/rg.210122

Coronary Artery Calcium Scoring: Current Status and ... Coronary artery calcium scoring has emerged as a widely available and powerful tool for stratifying cardiovascular risk, predicting outcomes, and guiding ...

10. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.050545

Very High Coronary Artery Calcium (≥1000) and ... Individuals with very high CAC (≥1000) are a unique population at substantially higher risk for CVD events, non-CVD outcomes, and mortality than those with ...