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Notification for Coronary Artery Calcification (PICTURE Trial)

N/A

Waitlist Available

Led By Fatima Rodriguez, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 and above and <85

Be older than 18 years old

Must not have

Advanced or poor-prognostic cancer

Age <18 or >85

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how notifying patients and doctors of coronary artery calcification (CAC) affects cardiovascular risk. Eligible patients will be randomized to CAC notification or usual care.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves notification rather than medication or invasive procedures, there are no direct side effects associated with the intervention itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 84 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am younger than 18 or older than 85.

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I am currently on medication to lower my cholesterol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Secondary study objectives

Atherosclerosis

Number of events requiring primary care intervention, cardiology referrals, or cardiac testing

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NotificationExperimental Treatment1 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 CareActive Control1 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 at the end of 6 months if we determine that notification is effective at increasing statin rates.

0 / 4Eligibility criteria met