## Protocol Section
### Identification Module
**NCT ID:** NCT06421363

**Acronym:** CAPRICI

**Brief Title:** Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease

**Official Title:** Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease

#### Organization Study ID Info
**ID:** CORONARIA 1/2023
#### Organization
**Class:** OTHER
**Full Name:** Hospital Clinico Universitario de Santiago
### Status Module
#### Completion Date
**Date:** 2027-08-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-24
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Jose Seijas Amigo

#### Responsible Party

**Investigator Affiliation:** Hospital Clinico Universitario de Santiago

**Investigator Full Name:** Jose Seijas Amigo

**Investigator Title:** PhD MS Pharmacy. Head of Clinical Trial Unit of Cardiology

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 1.1. Background Cardiovascular disease (CVD) remains the leading cause of death in our country for over four decades. The pathophysiology of CVD begins with various cardiovascular risk factors (CRFs) and their poor management, leading to subclinical lesions in target organs such as albuminuria or left ventricular hypertrophy, which may evolve into CVD. This progression is referred to as the cardiovascular continuum. Patients with chronic cardiovascular conditions require comprehensive periodic health monitoring in primary care (PC), including lifestyle advice and an assessment of comorbidities. Risk factors linked to disease progression are monitored and managed, along with medication reconciliation and planning follow-up care. Such activities, especially post-COVID, help maintain clinical stability and organize healthcare demand, reducing unnecessary interventions and costs. In Galicia, continuity of care programs for ischemic heart disease focus on optimizing service delivery at appropriate levels, including electronic consultations that improve healthcare accessibility, outcomes, and cost-effectiveness. Introducing Inclisiran for chronic CVD patients post-acute coronary syndrome (ACS) hospitalization might streamline care continuity, reducing healthcare costs and improving outcomes.

1.2. Purpose The disruption of care continuity in patients post-ACS increases their risk of mortality and hospitalizations due to coronary complications and comorbidities, as well as emergency visits and unplanned healthcare interactions, thus elevating healthcare costs. We propose reorganizing care continuity for ACS patients by establishing a PC pathway with scheduled semi-annual visits to assess overall and cardiovascular health and to evaluate patient prognosis and healthcare resource utilization.

2. Objectives 2.1. Primary Objectives The main goal is to evaluate whether a follow-up program incorporating Inclisiran treatment in patients with chronic coronary syndrome can optimize follow-up (reducing unscheduled visits to PC and hospital emergency departments), improve control of risk factors (like physical activity, adherence to a Mediterranean diet, lipid profiles, blood pressure, glycemic profile, and renal function), and decrease direct economic costs.

2.2. Secondary Objectives The secondary objectives include analyzing adherence to prescribed chronic pharmacological treatment, factors driving higher demand among patients with chronic coronary syndrome, reasons for emergency visits, hospital admissions, and causes of mortality among these patients.

3. Methodology 3.1. Study Design A pilot, multicentric, analytical intervention study will be conducted involving five health centers in the Santiago de Compostela health area, with specific inclusion and exclusion criteria outlined. The study will monitor patients over 27 months, following a detailed protocol.

### Conditions Module

**Conditions:**

- Ischemic Heart Disease

- Acute Coronary Syndrome

**Keywords:**

- inclisiran

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** CONTROL GROUP

**Type:** NO_INTERVENTION

#### Arm Group 2

**Intervention Names:**

- Drug: Inclisiran

**Label:** INTERVENTIONAL GROUP

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- INTERVENTIONAL GROUP

**Description:** Implementation of a follow-up program that incorporates Inclisiran treatment in patients with a history of chronic coronary syndrome

**Name:** Inclisiran

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Number of unplanned visits for patients with chronic coronary syndrome in family medicine, nursing, telemedicine, and hospital consultations during follow-up.

**Measure:** Change in Unplanned Medical Visits

**Time Frame:** 2 YEARS

**Description:** Change in adherence to the Mediterranean diet using the validated questionnaire PREDIMED. The test consists of 14 questions, in which the higher the score, the better the relationship with a healthy life.

TOTAL SCORE: \< 9 low adherence \>= 9 good adherence to the Mediterranean diet

**Measure:** Variation in Adherence to the Mediterranean Diet

**Time Frame:** 2 YEARS

**Description:** Change in LDL cholesterol levels in mg/dL from baseline to follow-up. Unit of Measure: mg/dL

**Measure:** Change in Lipid Profile.

**Time Frame:** 2 YEARS

**Description:** Change in systolic/diastolic blood pressure (specify how it's measured, e.g., mmHg).

Unit of Measure: mmHg.

**Measure:** Change in Blood Pressure

**Time Frame:** 2 YEARS

#### Secondary Outcomes

**Description:** Adherence to medication, measured as the proportion of days covered (PDC) based on the total number of days medications were supplied through the electronic prescription system.

Unit of Measure: Percentage (%) Calculation of the PDC for a specific drug: The numerator represents the total number of days a drug was supplied between the first and last electronic prescription picked up (a + b + c + d). The denominator represents the total number of days in the interval (from x to t). PDC: proportion of days covered.

**Measure:** Adherence to Medication

**Time Frame:** 2 YEARS

**Description:** Outcome Measure: Number of hospital emergency attendances during the study period.

Unit of Measure: Number of attendances.

**Measure:** Emergency Room Attendances

**Time Frame:** 2 YEARS

**Description:** Hospital Admissions Description: Number of hospital admissions related to cardiovascular disease Unit of Measure: Number of admissions Mortality Description: Number of deaths and primary cause during the study period. Unit of Measure: Number of admissions

**Measure:** Patient Prognosis

**Time Frame:** 2 YEARS

**Description:** Physical Activity Description: Change in physical activity, assessed via a validated questionnaire SF-36 Unit of Measure: Score on the questionnaire.

Scale Details:

Full Scale Name: Short Form (36) Health Survey Scale Range: The SF-36 scale typically ranges from 0 to 100. Interpretation: Higher scores indicate a better quality of life and health status.

**Measure:** Change in Patient Risk Factors

**Time Frame:** 2 YEARS

**Description:** Costs associated with unplanned medical visits, adherence, hospitalizations, and medication adherence.

Unit of Measure: Cost (currency)

**Measure:** Cost Analysis

**Time Frame:** 2 YEARS

**Description:** Outcome Measure: Number of unplanned nursing consultations in primary care.

Unit of Measure: Number of consultations.

**Measure:** Healthcare Organization 1

**Time Frame:** 2 years

**Description:** Outcome Measure: Number of unplanned family doctor consultations in primary care.

Unit of Measure: Number of consultations.

**Measure:** Healthcare Organization 2

**Time Frame:** 2 yeras

**Description:** Outcome Measure: Number of attendances at continuous care points in primary care.

Unit of Measure: Number of attendances.

**Measure:** Healthcare Organization 3

**Time Frame:** 2 years

**Description:** Outcome Measure: Number of telemedicine hospital consultations.

Unit of Measure: Number of consultations.

**Measure:** Healthcare Organization 4

**Time Frame:** 2 yeras

**Description:** Outcome Measure: Number of in-person hospital consultations.

Unit of Measure: Number of consultations.

**Measure:** Healthcare Organization 5

**Time Frame:** 2 years

**Description:** Outcome Measure: Number of hospital emergency attendances.

Unit of Measure: Number of attendances.

**Measure:** Healthcare Organization 5

**Time Frame:** 2 years

**Description:** Outcome Measure: Lab samples results.

Unit of Measure: Specific measure (e.g., mg/dL for cholesterol).

**Measure:** Lab samples results

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Age ≥18 years
2. Prior diagnosis of chronic coronary disease

   At least one of the following:
   1. Type 2 diabetes mellitus
   2. Familial hypercholesterolemia
   3. Recurrent coronary disease
   4. Chronic kidney disease
3. Currently undergoing pharmacological treatment with high-potency statins, with or without ezetimibe. The allowed statins and daily doses are:

   1. Atorvastatin 80mg
   2. Rosuvastatin 20mg
   3. Rosuvastatin 40mg
   4. Patients on other statins or lower doses are acceptable if there has been documented intolerance to the specified molecules and doses.
4. Blood analysis with a lipid profile in the last 6 months and with the current treatment showing LDL levels \>100mg/dl.

Exclusion Criteria:

1. Not receiving statins in the therapeutic regimen.
2. Concomitant treatment with PCSK9 inhibitors.
3. Pregnancy, breastfeeding, or a desire to conceive by the patient.
4. Patients who, in the opinion of the investigator, are unable to adequately follow up in the chronic care program under routine clinical practice.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** scinzas@semergen.es

**Name:** SERGIO CINZA SANJURJO, PHD MD

**Phone:** +34915002171

**Role:** CONTACT

**Contact 2:**

**Email:** jose.seijas.amigo@sergas.es

**Name:** JOSE SEIJAS AMIGO, PhD MS Pharm

**Phone:** +34981955764

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** A Estrada

**Contacts:**

***Contact 1:***

- **Name:** DANIEL REY ALDANA

- **Role:** CONTACT

***Contact 2:***

- **Name:** DANIEL REY ALDANA

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Cenro de Salud de La Estrada

**State:** A Coruña

**Location 2:**

**City:** Ames

**Contacts:**

***Contact 1:***

- **Email:** scinzas@semergen.es

- **Name:** SERGIO CINZA

- **Role:** CONTACT

***Contact 2:***

- **Name:** SERGIO CINZA SANJURJO

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** ANDREA GRELA BEIROA

- **Role:** SUB_INVESTIGATOR

**Country:** Spain

**Facility:** Centro de Salud de Milladoiro

**State:** A Coruña

**Location 3:**

**City:** Ribeira

**Contacts:**

***Contact 1:***

- **Name:** ISABEL REGO

- **Role:** CONTACT

***Contact 2:***

- **Name:** ISABEL REGO

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** ANA SUAREZ DIOS

- **Role:** SUB_INVESTIGATOR

**Country:** Spain

**Facility:** Centro de Salud de Ribeira

**State:** A Coruña

**Location 4:**

**City:** Santiago De Compostela

**Contacts:**

***Contact 1:***

- **Email:** jose.ramon.gonzalez.juanatey@sergas.es

- **Name:** JOSE RAMON GONZALEZ JUNATEY

- **Phone:** +34981950000

- **Role:** CONTACT

***Contact 2:***

- **Email:** jose.seijas.amigo@sergas.es

- **Name:** JOSE SEIJAS AMIGO

- **Phone:** +34981955764

- **Role:** CONTACT

***Contact 3:***

- **Name:** JOSE RAMON GONZALEZ JUANATEY

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** JOSE SEIJAS AMIGO

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** PILAR MAZON RAMOS

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** PALOMA SEMPERE

- **Role:** SUB_INVESTIGATOR

***Contact 7:***

- **Name:** FRANCISCO REYES SANTÍAS

- **Role:** SUB_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Clinico Univesitario de Santiago de Compostela

**State:** A Coruña

**Zip:** 15706

**Location 5:**

**City:** Melide

**Contacts:**

***Contact 1:***

- **Name:** MONICA BARRAL CARREGAL

- **Role:** CONTACT

***Contact 2:***

- **Name:** MONICA BARRAL CARREGAL

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Centro de Salud de Melide

**Location 6:**

**City:** Pontevedra

**Contacts:**

***Contact 1:***

- **Name:** TERESA FERREIRO

- **Role:** CONTACT

***Contact 2:***

- **Name:** TERESA FERREIRO

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Centro de Salud A Cañiza

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000003327

- Term: Coronary Disease

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Ischemic Heart Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: HIGH

- As Found: Ischemic Heart Disease

- ID: M9419

- Name: Heart Diseases

- Relevance: HIGH

- As Found: Heart Disease

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: HIGH

- As Found: Ischemic

- ID: M27545

- Name: Acute Coronary Syndrome

- Relevance: HIGH

- As Found: Acute Coronary Syndrome

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- 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: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006331

- Term: Heart Diseases

- ID: D000054058

- Term: Acute Coronary Syndrome

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000003324

- Term: Coronary Artery Disease

- ID: D000007511

- Term: Ischemia

### Misc Info Module

- Version Holder: 2024-05-31
