Clinical trial NCT06421363: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Ischemic Heart Disease
Acute Coronary Syndrome
Keywords: inclisiran
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Unplanned Medical Visits
timeFrame: 2 YEARS
measure: Variation in Adherence to the Mediterranean Diet
timeFrame: 2 YEARS
measure: Change in Lipid Profile.
timeFrame: 2 YEARS
measure: Change in Blood Pressure
timeFrame: 2 YEARS
Secondary outcomes:
measure: Adherence to Medication
timeFrame: 2 YEARS
measure: Emergency Room Attendances
timeFrame: 2 YEARS
measure: Patient Prognosis
timeFrame: 2 YEARS
measure: Change in Patient Risk Factors
timeFrame: 2 YEARS
measure: Cost Analysis
timeFrame: 2 YEARS
measure: Healthcare Organization 1
timeFrame: 2 years
measure: Healthcare Organization 2
timeFrame: 2 yeras
measure: Healthcare Organization 3
timeFrame: 2 years
measure: Healthcare Organization 4
timeFrame: 2 yeras
measure: Healthcare Organization 5
timeFrame: 2 years
measure: Healthcare Organization 5
timeFrame: 2 years
measure: Lab samples results
timeFrame: 2 years
Other outcomes:
Locations:
city: A Estrada
country: Spain
facility: Cenro de Salud de La Estrada
state: A Coruña
city: Ames
country: Spain
facility: Centro de Salud de Milladoiro
state: A Coruña
city: Ribeira
country: Spain
facility: Centro de Salud de Ribeira
state: A Coruña
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Univesitario de Santiago de Compostela
state: A Coruña
city: Melide
country: Spain
facility: Centro de Salud de Melide
city: Pontevedra
country: Spain
facility: Centro de Salud A Cañiza
Study officials:
References: