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

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Notification of patients and clinicians for coronary artery calcium in 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 decisions. Studies indicate that higher CAC scores are linked to a greater chance of heart issues, and informing patients and doctors about these scores can guide more effective risk-reducing treatments. ^{1 2 3 4 5}

Is the Notification of Coronary Artery Calcium for Heart Disease safe for humans?

There is no specific safety data available for the Notification of Coronary Artery Calcium for Heart Disease treatment in the provided research articles. ^{6 7 8 9 10}

How does the treatment of notifying patients and clinicians about coronary artery calcium differ from other treatments for heart disease?

This treatment is unique because it involves notifying patients and clinicians about the presence of coronary artery calcium, which is a marker of coronary artery disease. Unlike traditional treatments that focus on managing symptoms or reducing risk factors, this approach aims to provide early detection and risk assessment, potentially leading to more personalized and preventive care strategies. ^{2 11 12 13 14}

What is the purpose of this trial?

Estimate the impact of notifying both patients and their clinicians of the presence of incidental coronary artery calcium (CAC) on initiation of lipid-lowering therapy in patients with ASCVD who are not receiving lipid-lowering therapy.

Research Team

Fatima Rodriguez, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Notification with a CAC image Active Control 1 Intervention

Notification of presence of CAC with a CT scan image

Group II: Notification without a CAC image Active Control 1 Intervention

Notification of presence of CAC without a CT scan image

Group III: Usual care Placebo Group 1 Intervention

Usual care

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

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]

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]

References

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

Does CAC testing alter downstream treatment patterns for cardiovascular disease? [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

[Value of coronary artery calcium measurements in primary prevention]. [2018]

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

Postanalytical quality improvement: a College of American Pathologists Q-Probes study of elevated calcium results in 525 institutions. [2021]

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

A phantom study of the effect of heart rate, coronary artery displacement and vessel trajectory on coronary artery calcium score: potential for risk misclassification. [2021]

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

Association of coronary artery calcium with severity of myocardial ischemia in left anterior descending, left circumflex, and right coronary artery territories. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Differences between self-reported and verified adverse cardiovascular events in a randomised clinical trial. [2021]

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

The Cardiac Safety Research Consortium enters its second decade: An invitation to participate. [2018]

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

Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review. [2021]

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

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Coronary artery calcium and its relationship to coronary artery disease. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

[Detection and quantification of coronary calcification: an update]. [2016]

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

Association of coronary artery calcified plaque with clinical coronary heart disease in the National Heart, Lung, and Blood Institute's Family Heart Study. [2016]

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

Coronary artery calcium by digital cinefluoroscopy in patients with pain suggestive of an acute coronary syndrome. [2020]