Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease (CAPRICI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Coronary Syndrome; Ischemic Heart Disease
• Intervention / Treatment: Drug: Inclisiran

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: SERGIO CINZA SANJURJO, PHD MD; Phone Number: +34915002171; Email: scinzas@semergen.es
• Study Contact Backup: Name: JOSE SEIJAS AMIGO, PhD MS Pharm; Phone Number: +34981955764; Email: jose.seijas.amigo@sergas.es

Study Locations

• Spain
  • Melide, Spain
    • Centro de Salud de Melide
    • Contact: MONICA BARRAL CARREGAL
    • Principal Investigator: MONICA BARRAL CARREGAL
  • Pontevedra, Spain
    • Centro de Salud A Cañiza
    • Contact: TERESA FERREIRO
    • Principal Investigator: TERESA FERREIRO
  • A Coruña
    • A Estrada, A Coruña, Spain
      • Cenro de Salud de La Estrada
      • Contact: DANIEL REY ALDANA
      • Principal Investigator: DANIEL REY ALDANA
    • Ames, A Coruña, Spain
      • Centro de Salud de Milladoiro
      • Contact: SERGIO CINZA; Email: scinzas@semergen.es
      • Principal Investigator: SERGIO CINZA SANJURJO
      • Sub-Investigator: ANDREA GRELA BEIROA
    • Ribeira, A Coruña, Spain
      • Centro de Salud de Ribeira
      • Contact: ISABEL REGO
      • Principal Investigator: ISABEL REGO
      • Sub-Investigator: ANA SUAREZ DIOS
    • Santiago De Compostela, A Coruña, Spain, 15706
      • Hospital Clinico Univesitario de Santiago de Compostela
      • Contact: JOSE RAMON GONZALEZ JUNATEY; Phone Number: +34981950000; Email: jose.ramon.gonzalez.juanatey@sergas.es
      • Contact: JOSE SEIJAS AMIGO; Phone Number: +34981955764; Email: jose.seijas.amigo@sergas.es
      • Principal Investigator: JOSE RAMON GONZALEZ JUANATEY
      • Sub-Investigator: JOSE SEIJAS AMIGO
      • Sub-Investigator: PILAR MAZON RAMOS
      • Sub-Investigator: PALOMA SEMPERE
      • Sub-Investigator: FRANCISCO REYES SANTÍAS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: CONTROL GROUP
Experimental: INTERVENTIONAL GROUP	Drug: Inclisiran; Implementation of a follow-up program that incorporates Inclisiran treatment in patients with a history of chronic coronary syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Unplanned Medical Visits	Number of unplanned visits for patients with chronic coronary syndrome in family medicine, nursing, telemedicine, and hospital consultations during follow-up.	2 YEARS
Variation in Adherence to the Mediterranean Diet	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	2 YEARS
Change in Lipid Profile.	Change in LDL cholesterol levels in mg/dL from baseline to follow-up. Unit of Measure: mg/dL	2 YEARS
Change in Blood Pressure	Change in systolic/diastolic blood pressure (specify how it's measured, e.g., mmHg). Unit of Measure: mmHg.	2 YEARS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Medication	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.	2 YEARS
Emergency Room Attendances	Outcome Measure: Number of hospital emergency attendances during the study period. Unit of Measure: Number of attendances.	2 YEARS
Patient Prognosis	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	2 YEARS
Change in Patient Risk Factors	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.	2 YEARS
Cost Analysis	Costs associated with unplanned medical visits, adherence, hospitalizations, and medication adherence. Unit of Measure: Cost (currency)	2 YEARS
Healthcare Organization 1	Outcome Measure: Number of unplanned nursing consultations in primary care. Unit of Measure: Number of consultations.	2 years
Healthcare Organization 2	Outcome Measure: Number of unplanned family doctor consultations in primary care. Unit of Measure: Number of consultations.	2 yeras
Healthcare Organization 3	Outcome Measure: Number of attendances at continuous care points in primary care. Unit of Measure: Number of attendances.	2 years
Healthcare Organization 4	Outcome Measure: Number of telemedicine hospital consultations. Unit of Measure: Number of consultations.	2 yeras
Healthcare Organization 5	Outcome Measure: Number of in-person hospital consultations. Unit of Measure: Number of consultations.	2 years
Healthcare Organization 5	Outcome Measure: Number of hospital emergency attendances. Unit of Measure: Number of attendances.	2 years
Lab samples results	Outcome Measure: Lab samples results. Unit of Measure: Specific measure (e.g., mg/dL for cholesterol).	2 years

Collaborators and Investigators

• Sponsor: Jose Seijas Amigo

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: inclisiran
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Acute Coronary Syndrome
• Other Study ID Numbers: CORONARIA 1/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No