Back to resultsNotify 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
About this trial
This is an interventional health services research trial for Coronary Artery Disease
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
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
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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