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Incidental Coronary Calcification Quality Improvement Project (ICC QI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04789278
Recruitment Status : Active, not recruiting
First Posted : March 9, 2021
Last Update Posted : July 29, 2022
Sponsor:
Information provided by (Responsible Party):
Alexander Sandhu, Stanford University

Study Description
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Brief Summary:
This is a multi-center, randomized quality improvement project. At least 200 statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental coronary artery calcium (CAC) on a prior non-gated chest CT will be enrolled across the Stanford Healthcare System and the Palo Alto Veteran's Affairs Healthcare System. Patients will be randomized in a 1:1 fashion to notification or usual care arms. The primary aim of this project is to estimate the increase in 6-month statin prescription among statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental CAC on a non-gated chest CT who are randomized to receive notification of their findings vs. usual care.

Condition or disease Intervention/treatment Phase
Atherosclerotic Cardiovascular Disease Coronary Artery Disease Other: Notification Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Incidental Coronary Calcification Quality Improvement Project
Actual Study Start Date : March 30, 2021
Actual Primary Completion Date : January 15, 2022
Estimated Study Completion Date : September 15, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Notification

Patients randomized to notification will receive a message sent by either the electronic health record (EHR) patient portal or postal mail that will inform them of the CAC identified on their previous chest CT. It will provide an overview of CAC, an image of their chest CT, and a recommendation that they discuss this finding with their clinician. These clinicians will be notified of these findings via an earlier EHR message. Any treatment decisions will be made by the patient and their clinician.

Patients randomized to notification who are not prescribed a statin medication and do not have a documented discussion regarding statin therapy within three months will be sent a second message at that time. Their primary care providers will receive a second EHR message concurrently.

 Other: Notification
Notification of coronary calcium to the patient and their clinician
No Intervention: Usual Care
Both arms have previously had their CT scans reported according to standard clinical practice. This may include notification of the CAC in the imaging report. The usual care arm will not receive any additional notification beyond this standard of care during the project.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Statin Prescription [ Time Frame: Within 6 months ]
    Proportion of patients prescribed a statin


Secondary Outcome Measures :
  1. Statin Intensity [ Time Frame: 6 months ]
    Proportion of patients prescribed a high intensity, intermediate intensity, and low intensity statin

  2. Total Cholesterol Level [ Time Frame: 6 months ]
  3. LDL Cholesterol Level [ Time Frame: 6 months ]
  4. HDL Cholesterol Level [ Time Frame: 6 months ]
  5. Triglyceride Level [ Time Frame: 6 months ]
  6. Systolic Blood Pressure [ Time Frame: 6 months ]
  7. Number of Hypertension Medications [ Time Frame: 6 months ]
  8. Hemoglobin A1c Level [ Time Frame: 6 months ]
  9. Body Mass Index [ Time Frame: 6 months ]
  10. Pooled cohort equations estimated 10-year risk of atherosclerotic cardiovascular disease [ Time Frame: 6 months ]
  11. Rate of Aspirin Prescription [ Time Frame: 6 months ]
    Proportion of patients prescribed aspirin

  12. Number of primary Care Clinical Encounters [ Time Frame: 6 months ]
  13. Number of Cardiology Referrals [ Time Frame: 6 months ]
  14. Number of Cardiovascular Diagnostic Tests [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-gated chest CT between 2014-2019
  • The presence of CAC confirmed by manual review by an experienced radiologist
  • Stanford affiliated primary care provider or endocrinologist for Stanford healthcare system patients and VA primary care provider for VA patients with at least 1 encounter since 2018

Exclusion Criteria:

  • Current or prior statin or PCSK9 inhibitor therapy
  • Prior diagnosis of ASCVD (coronary artery disease, peripheral arterial disease, cerebrovascular disease, coronary/peripheral revascularization)
  • Prior coronary imaging (cardiac CT, invasive coronary angiography)
  • Dementia
  • Metastatic cancer or active cancer undergoing chemotherapy
  • History of medical nonadherence
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04789278


Locations
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United States, California
Stanford Hospital & Clinics
Stanford, California, United States, 94066
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Alexander T Sandhu, MD, MS Stanford University
  Study Documents (Full-Text)

Documents provided by Alexander Sandhu, Stanford University:
Study Protocol and Statistical Analysis Plan  [PDF] March 10, 2021

More Information
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Responsible Party: Alexander Sandhu, Principal Investigator, Instructor of Medicine, Division of Cardiology, Stanford University
ClinicalTrials.gov Identifier: NCT04789278    
Other Study ID Numbers: ICC-QI-2021
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexander Sandhu, Stanford University:
Coronary Calcium
Statin
Non-gated Chest CT
Additional relevant MeSH terms:
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Cardiovascular Diseases
Coronary Artery Disease
Atherosclerosis
Coronary Disease
Myocardial Ischemia
 Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases