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

Acute Coronary Syndrome Clinical Trial

— CAPRICI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06421363
• Other study ID #: CORONARIA 1/2023
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2024
• Est. completion date: August 1, 2027

Study information

• Verified date: May 2024
• Source: Hospital Clinico Universitario de Santiago
• Contact: SERGIO CINZA SANJURJO, PHD MD
• Phone: +34915002171
• Email: scinzas[@]semergen.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 1, 2027
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Spain	Cenro de Salud de La Estrada	A Estrada	A Coruña
Spain	Centro de Salud de Milladoiro	Ames	A Coruña
Spain	Centro de Salud de Melide	Melide
Spain	Centro de Salud A Cañiza	Pontevedra
Spain	Centro de Salud de Ribeira	Ribeira	A Coruña
Spain	Hospital Clinico Univesitario de Santiago de Compostela	Santiago De Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Jose Seijas Amigo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in Lipid Profile.	Change in LDL cholesterol levels in mg/dL from baseline to follow-up. Unit of Measure: mg/dL	2 YEARS
Primary	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	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
Secondary	Emergency Room Attendances	Outcome Measure: Number of hospital emergency attendances during the study period.; Unit of Measure: Number of attendances.	2 YEARS
Secondary	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
Secondary	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
Secondary	Cost Analysis	Costs associated with unplanned medical visits, adherence, hospitalizations, and medication adherence.; Unit of Measure: Cost (currency)	2 YEARS
Secondary	Healthcare Organization 1	Outcome Measure: Number of unplanned nursing consultations in primary care.; Unit of Measure: Number of consultations.	2 years
Secondary	Healthcare Organization 2	Outcome Measure: Number of unplanned family doctor consultations in primary care.; Unit of Measure: Number of consultations.	2 yeras
Secondary	Healthcare Organization 3	Outcome Measure: Number of attendances at continuous care points in primary care.; Unit of Measure: Number of attendances.	2 years
Secondary	Healthcare Organization 4	Outcome Measure: Number of telemedicine hospital consultations.; Unit of Measure: Number of consultations.	2 yeras
Secondary	Healthcare Organization 5	Outcome Measure: Number of in-person hospital consultations.; Unit of Measure: Number of consultations.	2 years
Secondary	Healthcare Organization 5	Outcome Measure: Number of hospital emergency attendances.; Unit of Measure: Number of attendances.	2 years
Secondary	Lab samples results	Outcome Measure: Lab samples results.; Unit of Measure: Specific measure (e.g., mg/dL for cholesterol).	2 years