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

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05394181

Enrollment

Registered

2022-05-27

Start date

2022-08-01

Completion date

2023-03-15

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

OTHERNotification

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. Age greater than or equal to 18 and less than 85 2. 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 3. Encounter with Palo Alto VA affiliated primary care since 2020

Exclusion criteria

1. Prior diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease 2. Dementia 3. Metastatic cancer or active cancer undergoing chemotherapy 4. CT coronary angiogram since 2016 5. Invasive Coronary angiogram since 2016 6. CAC scan since 2016 7. Statin therapy within prior 6 months 8. Prior ezetimibe or PCSK9 inhibitor therapy 9. Prior rhabdomyolysis with statin therapy 10. Schizophrenia 11. Substance abuse disorder (alcohol, amphetamines, cocaine, opioids) 12. Hospice 13. Pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Statin prescription rate	4 months	Prescription of statin medication

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026