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

NCT06421363 | Not Yet Recruiting Phase 4

• 1 other identifier: CORONARIA 1/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

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

Ischemic Heart Disease; Acute Coronary Syndrome

Keywords

inclisiran

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Adherence to Medication

  2 YEARS

• Emergency Room Attendances

  2 YEARS

• Patient Prognosis

  2 YEARS

• Change in Patient Risk Factors

  2 YEARS

• Cost Analysis

  2 YEARS

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

INTERVENTIONAL GROUP

EXPERIMENTAL

Drug: Inclisiran

Interventions

Inclisiran DRUG

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

INTERVENTIONAL GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Prior diagnosis of chronic coronary disease
• At least one of the following:
• Type 2 diabetes mellitus
• Familial hypercholesterolemia
• Recurrent coronary disease
• Chronic kidney disease
• Currently undergoing pharmacological treatment with high-potency statins, with or without ezetimibe. The allowed statins and daily doses are:
• Atorvastatin 80mg
• Rosuvastatin 20mg
• Rosuvastatin 40mg
• Patients on other statins or lower doses are acceptable if there has been documented intolerance to the specified molecules and doses.
• Blood analysis with a lipid profile in the last 6 months and with the current treatment showing LDL levels \>100mg/dl.

You may not qualify if:

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

Sponsors & Collaborators

• Jose Seijas Amigo: lead

Study Sites (6)

Cenro de Salud de La Estrada

A Estrada, A Coruña, Spain

Location

Centro de Salud de Milladoiro

Ames, A Coruña, Spain

Location

Centro de Salud de Ribeira

Ribeira, A Coruña, Spain

Location

Hospital Clinico Univesitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

Centro de Salud de Melide

Melide, Spain

Location

Centro de Salud A Cañiza

Pontevedra, Spain

Location

MeSH Terms

Conditions

Myocardial Ischemia; Acute Coronary Syndrome

Interventions

ALN-PCS

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

SERGIO CINZA SANJURJO, PHD MD

CONTACT

+34915002171; scinzas@semergen.es

JOSE SEIJAS AMIGO, PhD MS Pharm

CONTACT

+34981955764; jose.seijas.amigo@sergas.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD MS Pharmacy. Head of Clinical Trial Unit of Cardiology

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 20, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)