## Protocol Section
### Identification Module
**NCT ID:** NCT05858879

**Acronym:** NOTIFY-ASCVD

**Brief Title:** Notification of Incidental Coronary Artery Calcium in Patients With Atherosclerotic Cardiovascular Disease (NOTIFY-ASCVD)

**Official Title:** Notification of Incidental Coronary Artery Calcium in Patients With Atherosclerotic Cardiovascular Disease (NOTIFY-ASCVD)

#### Organization Study ID Info
**ID:** 70362
#### Organization
**Class:** OTHER
**Full Name:** Stanford University
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-12

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-07

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2023-05-15
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-05
**Study First Submit QC Date:** 2023-05-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Stanford University

#### Responsible Party

**Investigator Affiliation:** Stanford University

**Investigator Full Name:** Fatima Rodriguez

**Investigator Title:** Associate Professor of Medicine (Cardiovascular Medicine)

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Estimate the impact of notifying both patients and their clinicians of the presence of incidental coronary artery calcium (CAC) on initiation of lipid-lowering therapy in patients with ASCVD who are not receiving lipid-lowering therapy.

**Detailed Description:** This is a randomized quality improvement (QI) project evaluating the impact of notifying patients and their clinicians (primary care, cardiologists, neurologists, or vascular surgeon) of incidental CAC detected on a prior chest CT scan. Patients will be identified by screening previous non-gated chest CT scans and electronic health records. The presence of CAC will be confirmed by a radiologist. Eligible patients will be randomized to: 1) notification of presence of CAC with a CT scan image; 2) notification of presence of CAC without a CT scan image; 3) or usual care.

### Conditions Module

**Conditions:**

- ASCVD

- Coronary Artery Calcification

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Eligible patients will be randomized to: 1) notification of presence of CAC with a CT scan image; 2) notification of presence of CAC without a CT scan image; 3) or usual care.

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** In the usual care arm, patients or clinicians will not be notified.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Notification of presence of CAC with a CT scan image

**Intervention Names:**

- Other: Notification of patients and clinicians

**Label:** Notification with a CAC image

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Notification of presence of CAC without a CT scan image

**Intervention Names:**

- Other: Notification of patients and clinicians

**Label:** Notification without a CAC image

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Usual care

**Intervention Names:**

- Other: Notification of patients and clinicians

**Label:** Usual care

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Notification with a CAC image

- Notification without a CAC image

- Usual care

**Description:** Notification Patients randomized to notification will receive a message sent by either the electronic health record (EHR) patient portal or US mail that will inform them of the CAC identified on their previous chest CT scan and a recommendation that they discuss this finding and initiation of lipid-lowering therapy with their clinician. The clinicians will be notified of these findings by an earlier EHR message that will be sent 2 weeks before the patient notification.

Usual Care The usual care arm will not receive any additional notification beyond this standard of care.

**Name:** Notification of patients and clinicians

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Number of patients who had initiation of lipid-lowering therapy

**Measure:** Initiation of lipid-lowering therapy

**Time Frame:** Month 6

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Presence of CAC on non-gated chest CT scans performed from 2021 to 2023
2. Age \<85 years
3. Diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
4. Visit to Stanford affiliated clinician since 2021 at one of the following Stanford clinics including University affiliated clinics:

   1. Internal Medicine
   2. Family Medicine
   3. Cardiology
   4. Neurology
   5. Vascular surgery

Exclusion Criteria:

1. No diagnosis of ASCVD
2. Patients receiving lipid-lowering therapy
3. Dementia
4. Metastatic cancer or active cancer undergoing chemotherapy

**Maximum Age:** 84 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** fahim@stanford.edu

**Name:** Fahim Abbasi, MD

**Phone:** 650-624-0954

**Role:** CONTACT

**Contact 2:**

**Name:** Sarah Magee

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Stanford University

**Name:** Fatima Rodriguez, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M26188

- Name: Atherosclerosis

- Relevance: HIGH

- As Found: Atherosclerotic Cardiovascular Disease

- ID: M5377

- Name: Calcinosis

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000050197

- Term: Atherosclerosis

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

### Intervention Browse Module - Browse Leaves

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
