Notification of Coronary Artery Calcium for Heart Disease

(NOTIFY-ASCVD Trial)

Overseen By Sarah Magee

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Lipid-lowering therapy

Disqualifiers: Dementia, Metastatic cancer, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how notifying patients and their doctors about coronary artery calcium (CAC) can initiate lipid-lowering therapy. CAC indicates heart disease, and the trial examines whether providing this information, with or without a CT scan image, encourages treatment for patients with atherosclerotic cardiovascular disease (ASCVD) who are not yet on such therapy. Individuals with CAC from past scans and coronary, peripheral, or cerebrovascular disease, but not on lipid-lowering medication, might be suitable candidates. The trial includes different groups: one receiving a notification with a CT scan image, another without the image, and a usual care group. As an unphased trial, this study offers a unique opportunity to understand how information can impact treatment decisions.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, if you are already on lipid-lowering therapy, you would not be eligible to participate.

What prior data suggests that this notification method is safe?

Research has shown that specific safety information about informing patients and doctors about coronary artery calcium (CAC) is lacking in existing studies. CAC, visible in CT scans, often predicts heart disease risk. The notification process involves only sharing information, not administering medication or performing risky procedures. As the trial does not test a new drug or device, there are no direct safety concerns related to the notification itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how informing patients and clinicians about coronary artery calcium (CAC) can impact heart disease management. Unlike standard treatments that focus directly on lowering cholesterol or blood pressure through medication, this approach aims to enhance patient and clinician awareness by using CT scan images to visualize CAC. This could lead to more personalized and proactive care strategies, potentially prompting earlier lifestyle changes or medical interventions. By comparing notification with and without a CT scan image, the trial seeks to determine the most effective way to communicate the presence of CAC and motivate preventive action.

What evidence suggests that notifying patients and clinicians of coronary artery calcium is effective for initiating lipid-lowering therapy in ASCVD patients?

Research has shown that knowledge of coronary artery calcium (CAC) can help identify individuals at higher risk of heart problems. In this trial, participants will be divided into groups: one group will receive notification of CAC presence with a CT scan image, another will receive notification without an image, and a third will receive usual care. Studies have found that when patients and doctors learn about CAC, they are more likely to start treatments like statins, which lower cholesterol. Specifically, one study found that 51% of those informed about their CAC began taking statins, compared to just 7% who received regular care. Additionally, a high CAC score is linked to a greater risk of heart issues and death, beyond what traditional risk factors predict. This suggests that informing patients and doctors about CAC could lead to better health decisions and outcomes. ^{1 3 6 7 8}

Who Is on the Research Team?

Fatima Rodriguez, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for patients under 85 years old with atherosclerotic cardiovascular disease (like coronary artery disease) who have been found to have calcium in their heart arteries on CT scans and are not currently on lipid-lowering therapy. It's open to those seen by internal medicine, family medicine, cardiology, neurology, or vascular surgery.

Inclusion Criteria

I am younger than 85 years old.

Visit to Stanford affiliated clinician since 2021 at one of the following Stanford clinics including University affiliated clinics: Internal Medicine, Family Medicine, Cardiology, Neurology, Vascular surgery

Presence of CAC on non-gated chest CT scans performed from 2021 to 2023

Exclusion Criteria

I have been diagnosed with dementia.

My cancer has spread, or I am currently on chemotherapy.

I am on medication to lower my cholesterol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Notification

Participants and their clinicians are notified of incidental coronary artery calcium detected on prior chest CT scans

Immediate

Follow-up

Participants are monitored for initiation of lipid-lowering therapy

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Notification of patients and clinicians

Trial Overview The study aims to see if telling both patients and doctors about the presence of calcium in heart arteries affects how often they start taking medication to lower lipids (fats in blood) which can help prevent heart problems.

How Is the Trial Designed?

Group I: Notification without a CAC image Experimental Treatment 1 Intervention

Notification of presence of CAC without a CT scan image and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy.

Group II: Notification with a CAC image Experimental Treatment 1 Intervention

Notification of presence of CAC with a CT scan image and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy.

Group III: Usual care Active Control 1 Intervention

The usual care arm will not receive any additional notification beyond the standard of care. If the intervention is successful, we will notify patients in the usual care arm of the presence of CAC and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

A new electronic health record (EHR)-based system allowed 26 clinicians to submit 217 adverse drug event (ADE) reports to the FDA in real-time, demonstrating an efficient method for reporting that took an average of just 53 seconds per report.

The system provided detailed clinical information about the ADEs, including comorbid conditions and concurrent medications, which could enhance the quality of data submitted to the FDA and potentially improve drug safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting. Linder, JA., Haas, JS., Iyer, A., et al.[2019]

Coronary calcifications are a key indicator of coronary heart disease (CHD) and their presence can help diagnose atherosclerotic disease in asymptomatic individuals with risk factors, potentially before any symptoms appear.

Calcium scoring using advanced imaging techniques like electron beam computed tomography (EBCT) and multi-slice CT allows for precise quantification of coronary calcifications, but the long-term prognostic value of these scores in asymptomatic high-risk patients is still uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Detection and quantification of coronary calcification: an update]. Fischbach, R., Heindel, W.[2016]

Between 2010 and 2016, 164 safety advisories regarding cardiac-related adverse events were issued by regulators in Australia, Canada, the UK, and the US, highlighting the prevalence of risks associated with 61 different drugs, primarily involving cardiac arrhythmias and coronary artery disorders.

While monitoring patients was the most common recommendation in these advisories, only 41.2% provided detailed guidance on how to conduct this monitoring, indicating a need for more consistent and comprehensive information for healthcare professionals and consumers regarding rare but serious medication harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. Hooimeyer, A., Bhasale, A., Perry, L., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-cardiovascular-diseases-6-2023-e3a21

Notification of Coronary Artery Calcium for Heart Disease ... Research shows that knowing about coronary artery calcium (CAC) can help identify people at higher risk of heart problems, which can lead to better treatment ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8723785/

Coronary Artery Calcium Score - A Reliable Indicator of ... The coronary artery calcium (CAC) score has been created as a measure of coronary atherosclerosis. This article has compiled various studies.

3. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001382

Opportunistic Detection of Coronary Artery Calcium on ... Among statin-eligible individuals, the notification arm had a statin prescription rate of 51%, versus 7% for the usual care group, at 6 months, ...

4. jacc.org jacc.org/doi/10.1016/j.jacc.2023.06.040

Association of Coronary Artery Calcium Detected by ... Incidental CAC ≥100 was associated with an increased risk of all-cause death and adverse cardiovascular outcomes, beyond traditional risk factors.

5. journalofcardiovascularct.com journalofcardiovascularct.com/article/S1934-5925(18)30058-3/fulltext

CAC-DRS: Coronary Artery Calcium Data and Reporting ... The goal of CAC-DRS: Coronary Artery Calcium Data and Reporting System is to create a standardized method to communicate findings of CAC ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9880346/

Coronary Artery Calcium Data and Reporting System (CAC ... The Coronary Artery Calcium Data and Reporting System (CAC-DRS) is a standardized reporting method for calcium scoring on computed tomography.

7. pubs.rsna.org pubs.rsna.org/doi/10.1148/ryct.240548

Coronary Artery Calcium Scoring on Dedicated Cardiac CT ... This review outlines the fundamentals of CAC scoring, with a focus on detection and quantification of incidental CAC. It details the technical ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5487233/

Coronary artery calcium score: current status - PMC Coronary calcium independently predicts incident premature coronary heart disease over measured cardiovascular risk factors: mean three-year outcomes in the ...