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Notification of Coronary Artery Calcium for Heart Disease (NOTIFY-ASCVD 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 <85 years
Diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
Must not have
Dementia
Metastatic cancer or active cancer undergoing chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6

Summary

This trial will look at how informing patients and their doctors about incidental findings of coronary artery calcium affects the start of cholesterol-lowering treatment in patients with heart disease who are not currently on such medication.

Who is the study for?
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.
What is being tested?
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am younger than 85 years old.
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I have been diagnosed with a heart or blood vessel disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with dementia.
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My cancer has spread, or I am currently on chemotherapy.
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I am on medication to lower my cholesterol.
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I have never been diagnosed with atherosclerotic cardiovascular disease.

Timeline

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
Initiation of lipid-lowering therapy

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Notification with a CAC imageActive Control1 Intervention
Notification of presence of CAC with a CT scan image
Group II: Notification without a CAC imageActive Control1 Intervention
Notification of presence of CAC without a CT scan image
Group III: Usual carePlacebo Group1 Intervention
Usual care

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Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,467 Previous Clinical Trials
17,495,102 Total Patients Enrolled
Fatima Rodriguez, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
202 Total Patients Enrolled
~250 spots leftby Jan 2025
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