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

• Sponsor: Stanford University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05394181
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7.4
• Patients Per Site Per Month: 80.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Other: Notification	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Notify 2: An Evaluation of the Impact of Notification of Incidental Coronary Artery Calcium on Statin Rates
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Jan 15, 2023
• Anticipated Study Completion Date: Mar 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Notification Notification of the presence of at least moderate coronary artery calcium on a prior non-gated chest CT	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
No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures

1. Statin prescription rate [4 months]

   Prescription of statin medication

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palo Alto Veteran's Affairs Hospital	Palo Alto	California	United States	94304

Sponsors and Collaborators

• Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexander Sandhu, Instructor of Medicine, Stanford University
• ClinicalTrials.gov Identifier: NCT05394181
• Other Study ID Numbers: 64798
• First Posted: May 27, 2022
• Last Update Posted: May 27, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

No Results Posted as of May 27, 2022