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Notification for Coronary Artery Calcification (PICTURE Trial)
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights
PICTURE Trial 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.Check my eligibility
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.See study design
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.
PICTURE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 84 years old.
PICTURE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Secondary outcome measures
Atherosclerosis
Body Weight Changes
Number of events requiring primary care intervention, cardiology referrals, or cardiac testing
+1 morePICTURE 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.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,050 Total Patients Enrolled
Fatima Rodriguez, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
1,000 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is in an advanced stage or has a poor outlook.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.I am younger than 18 or older than 85.I am currently on medication to lower my cholesterol.I am between 18 and 84 years old.You are allergic to statin medication or have experienced muscle symptoms while taking statins.
Research Study Groups:
This trial has the following groups:- Group 1: Notification
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applicants above the age of 18 eligible for enrollment in this experiment?
"As outlined in the study's requirements, candidates must be of legal age and no older than 89 to take part."
Answered by AI
Are there current openings in this research study for participants?
"According to clinicaltrials.gov, this particular clinical trial is not currently accepting new candidates. This research initiative was first posted on November 1st 2022 and the most recent update arrived on October 17th 20212. Although recruitment for this study has been halted, there are 29 other trials actively seeking participants at present."
Answered by AI
What are the criteria for being eligible to partake in this medical research?
"This research is seeking out 300 patients aged between 18 and 89 who currently have coronary artery disease. All volunteers must also meet the following qualifications: Age younger than 90, possess a non-gated chest CT along with CAC, be affiliated with Stanford Internal Medicine or Stanford Family Medicine clinics."
Answered by AI
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