NCT06421363Not yet recruitingPhase 4
Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease
Source: ClinicalTrials.gov · Last updated 20 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 24 Apr 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Jose Seijas Amigo
- Diseases
- Coronary artery disease
- NCT number
- NCT06421363
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From 1 Jun 2024 to the primary completion date, 1 Jun 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Not receiving statins in the therapeutic regimen.
- Concomitant treatment with PCSK9 inhibitors.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cenro de Salud de La Estrada Coordinator of this site? Confirm its status | A Estrada | Spain | Unknown status |
| Centro de Salud de Milladoiro Coordinator of this site? Confirm its status | Ames | Spain | Unknown status |
| Centro de Salud de Melide Coordinator of this site? Confirm its status | Melide | Spain | Unknown status |
| Centro de Salud A Cañiza Coordinator of this site? Confirm its status | Pontevedra | Spain | Unknown status |
| Centro de Salud de Ribeira Coordinator of this site? Confirm its status | Ribeira | Spain | Unknown status |
| Hospital Clinico Univesitario de Santiago de Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.