Notification for Coronary Artery Calcification

(PICTURE Trial)

Overseen By Shiqin Xu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Statins, Non-statin lipid-lowering

Disqualifiers: Advanced cancer, No active care, 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 aims to determine if informing patients about coronary artery calcification (CAC) found during a chest CT scan can aid in managing cardiovascular risk. CAC indicates potential artery hardening, which can lead to heart problems. The study compares two groups: one receives notifications about their CAC, while the other receives standard care without additional notifications. Individuals who have had a chest CT scan showing CAC and receive care from Stanford-affiliated clinics might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding how patient awareness of CAC can affect heart health management.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on statin or non-statin lipid-lowering therapy, you are not eligible to participate.

What prior data suggests that this notification protocol is safe?

Research has shown that informing patients about coronary artery calcification (CAC) is generally safe, as it involves merely sharing information. CAC refers to a build-up of calcium in the heart's arteries. Although not a treatment, awareness of CAC can aid patients and doctors in making better health decisions.

Studies indicate that a high CAC score can signify a higher risk of heart problems, but being informed about it has no known side effects. This trial focuses on clearly communicating CAC findings. The safety of this process is supported by its non-invasive nature, as it involves simply conveying important health information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for coronary artery calcification notification because it explores whether timely communication can influence treatment decisions. Unlike standard care, which merely notes coronary artery calcification (CAC) in radiology reports, this approach directly notifies both the patient's cardiologist and the patient themselves, creating a prompt for action. This could potentially lead to earlier interventions, like starting statin therapy, which might reduce cardiovascular risks. The trial aims to understand if proactive communication can drive better health outcomes, potentially changing how doctors handle CAC findings.

What evidence suggests that notifying patients of coronary artery calcification is effective for increasing statin use?

This trial will compare the effects of notifying patients about coronary artery calcification (CAC) with usual care. Research has shown that informing patients about CAC is crucial for their health. Studies have found a high CAC score links to worse heart health. For example, CAC scores over 400 indicate a higher risk of heart problems. In this trial, participants in the notification arm will receive standardized messages about their CAC scores, which can enhance communication between doctors and patients. This improved communication can help patients make informed decisions about their treatment, such as starting or adjusting medication. Overall, awareness of CAC is a vital step in managing heart health and preventing serious issues. ^{1 2 5 6 7}

Who Is on the Research Team?

Fatima Rodriguez, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

The PICTURE trial is for adults aged 18 to under 85 who've had a non-gated chest CT scan showing coronary artery calcification, and have seen a Stanford-affiliated clinician since January 1, 2020. It's not for those already on cholesterol-lowering meds, with advanced cancer, without active primary care at Stanford Health Care, outside the age range, or with statin allergies.

Inclusion Criteria

Chest CT scan without calcium scoring.

You saw a doctor at Stanford Internal Medicine, Stanford Family Medicine, or a non-EP cardiologist after January 1, 2020.

Exclusion Criteria

My cancer is in an advanced stage or has a poor outlook.

No active primary care at Stanford Health Care

Non-English or non-Spanish speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Notification

Eligible patients are randomized to either CAC notification or usual care. Notification involves sending a standardized message to the patient's clinician and, after a delay, to the patient.

2 weeks

Follow-up

Participants are monitored for changes in statin prescription rates and healthcare resource use.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Notification

Trial Overview This study tests whether notifying patients and their doctors about incidental findings of heart artery calcification from chest CT scans affects cardiovascular risk management. Participants are randomly placed into two groups: one receives notification of their CAC results; the other continues usual care without specific notification.

How Is the Trial Designed?

Group I: Notification Experimental Treatment 1 Intervention

The notification arm will have its CT scans interpreted and reported according to standard clinical practice. A standardized notification message using the EHR will be sent to the patient's Stanford affiliated non-EP cardiologist, if present, or the primary care clinician if there is no non-EP cardiologist. After a two week delay from notifying the patient's non-EP cardiologist or PCP, a standardized notification message will be sent to the patient. The message will include an image of the CAC from the chest CT. All communications will be signed by the Principal Investigator. Any treatment decisions will be made by the patient and their clinician.

Group II: Usual Care Active Control 1 Intervention

The usual care arm will have its CT scans interpreted and reported according to standard clinical practice. This may mention the presence of CAC in the official radiology imaging report, per usual practice. The usual care arm will not receive any notification beyond this standard of care. We intend to notify patients in the usual care arm when study ends, if we determine that notification is effective at increasing statin rates.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

An automated email notification system was implemented to inform physicians about finalized test results pending at discharge (TPADs), improving communication and responsibility transfer between inpatient and primary care physicians.

During a 6-month pilot involving randomly selected inpatient-attending physicians, 84% reported satisfaction with the system, indicating its effectiveness in managing TPADs with an average of 1.6 notifications per discharged patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of an automated email notification system for results of tests pending at discharge. Dalal, AK., Schnipper, JL., Poon, EG., et al.[2021]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK519037/

Coronary Artery Calcification - StatPearls - NCBI Bookshelf A CAC score over 400 is associated with worsened clinical outcomes. These scenarios illustrate the ability of CAC scoring to help reclassify the ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.065657

Coronary Artery Calcification: Current Concepts and ... This review summarizes the current understanding and literature on CAC. It outlines the pathophysiology of CAC and reviews laboratory, histopathological, and ...

3. withpower.com withpower.com/trial/phase-coronary-artery-calcifications-10-2022-e403b

Notification for Coronary Artery Calcification (PICTURE Trial) The research suggests that using automated notification systems can improve communication of critical test results, which may enhance patient safety and reduce ...

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. 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.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1936879820309274

Coronary Calcification and Long-Term Outcomes ... The aim of this study was to evaluate the long-term impact of coronary artery calcification (CAC) on outcomes after percutaneous coronary intervention.

7. jcvaonline.com jcvaonline.com/article/S1053-0770(24)00432-4/fulltext

Navigating Coronary Calcifications Coronary artery calcification (CAC) is a related finding of calcific lesions in the coronary circulation.