Notify 2: An Evaluation of the Impact of Notification of Incidental Coronary Artery Calcium on Statin Rates

NCT05394181 | Withdrawn

• 1 other identifier: 64798
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to estimate the impact of notification of primary care provider and patient of at least moderate incidental coronary artery calcification (CAC) on a prior non-gated chest CT on statin prescription rates at 4 months among patients without a clinical history of atherosclerotic cardiovascular disease not actively on statin therapy. This study will determine if notifying patients and their primary care clinician about an existing finding will influence shared decision-making around statins between patients and their primary care clinician.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Statin prescription rate

  Prescription of statin medication

  4 months

Study Arms (2)

Notification

EXPERIMENTAL

Notification of the presence of at least moderate coronary artery calcium on a prior non-gated chest CT

Other: Notification

Usual Care

NO INTERVENTION

Interventions

Notification OTHER

Notification of patient and primary care clinician of presence of at least moderate coronary artery calcium on a prior non-gated chest CT

Notification

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 and less than 85
• Non-gated chest CT from 1/1/2016-6/30/2020 with algorithm screening estimating CAC score of at least 100 Agatston Units with radiologist confirmation of moderate or severe CAC
• Encounter with Palo Alto VA affiliated primary care since 2020

You may not qualify if:

• Prior diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
• Dementia
• Metastatic cancer or active cancer undergoing chemotherapy
• CT coronary angiogram since 2016
• Invasive Coronary angiogram since 2016
• CAC scan since 2016
• Statin therapy within prior 6 months
• Prior ezetimibe or PCSK9 inhibitor therapy
• Prior rhabdomyolysis with statin therapy
• Schizophrenia
• Substance abuse disorder (alcohol, amphetamines, cocaine, opioids)
• Hospice
• Pregnancy

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Palo Alto Veteran's Affairs Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: August 1, 2022
• Primary Completion: January 15, 2023
• Study Completion: March 15, 2023
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)