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

NCT ID: NCT06421363

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2027-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CONTROL GROUP

Group Type: NO_INTERVENTION

No interventions assigned to this group

INTERVENTIONAL GROUP

Group Type: EXPERIMENTAL

Inclisiran

Intervention Type: DRUG

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

Interventions

Inclisiran

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

Intervention Type: DRUG

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 Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jose Seijas Amigo

OTHER

Sponsor Role: lead

Responsible Party

Jose Seijas Amigo

PhD MS Pharmacy. Head of Clinical Trial Unit of Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cenro de Salud de La Estrada

A Estrada, A Coruña, Spain

Centro de Salud de Milladoiro

Ames, A Coruña, Spain

Centro de Salud de Ribeira

Ribeira, A Coruña, Spain

Hospital Clinico Univesitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Centro de Salud de Melide

Melide, , Spain

Centro de Salud A Cañiza

Pontevedra, , Spain

Countries

Spain

Central Contacts

SERGIO CINZA SANJURJO, PHD MD

Role: CONTACT

scinzas@semergen.es

+34915002171

JOSE SEIJAS AMIGO, PhD MS Pharm

Role: CONTACT

jose.seijas.amigo@sergas.es

+34981955764

Facility Contacts

DANIEL REY ALDANA

Role: primary

SERGIO CINZA

Role: primary

scinzas@semergen.es

ISABEL REGO

Role: primary

JOSE RAMON GONZALEZ JUNATEY

Role: primary

jose.ramon.gonzalez.juanatey@sergas.es

+34981950000

JOSE SEIJAS AMIGO

Role: backup

jose.seijas.amigo@sergas.es

+34981955764

MONICA BARRAL CARREGAL

Role: primary

TERESA FERREIRO

Role: primary

Other Identifiers

CORONARIA 1/2023

Identifier Type: -

Identifier Source: org_study_id