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

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Notification
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Palo Alto Veteran's Affairs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Notification

Usual Care

Arm Description

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

Outcomes

Primary Outcome Measures

Statin prescription rate
Prescription of statin medication

Secondary Outcome Measures

Full Information

First Posted
May 24, 2022
Last Updated
May 24, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05394181
Brief Title
Notify 2: An Evaluation of the Impact of Notification of Incidental Coronary Artery Calcium on Statin Rates
Official Title
Notify 2: An Evaluation of the Impact of Notification of Incidental Coronary Artery Calcium on Statin Rates
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
January 15, 2023 (Anticipated)
Study Completion Date
March 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Notification
Arm Type
Experimental
Arm Description
Notification of the presence of at least moderate coronary artery calcium on a prior non-gated chest CT
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Notification
Intervention Description
Notification of patient and primary care clinician of presence of at least moderate coronary artery calcium on a prior non-gated chest CT
Primary Outcome Measure Information:
Title
Statin prescription rate
Description
Prescription of statin medication
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Palo Alto Veteran's Affairs Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander T Sandhu, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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