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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05394181
• Other study ID #: 64798
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: March 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
United States	Palo Alto Veteran's Affairs Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Statin prescription rate	Prescription of statin medication	4 months