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临床试验/NCT06421363
NCT06421363尚未招募4 期

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

Jose Seijas Amigo6 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50
试验地点
6
主要终点
Change in Lipid Profile.

研究概览

简要总结

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.

  1. 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.

  1. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

INTERVENTIONAL GROUP

Experimental

干预措施: Inclisiran (Drug)

结局指标

主要结局

Change in Lipid Profile.

时间窗: 2 YEARS

Change in LDL cholesterol levels in mg/dL from baseline to follow-up. Unit of Measure: mg/dL

Change in Unplanned Medical Visits

时间窗: 2 YEARS

Number of unplanned visits for patients with chronic coronary syndrome in family medicine, nursing, telemedicine, and hospital consultations during follow-up.

Change in Blood Pressure

时间窗: 2 YEARS

Change in systolic/diastolic blood pressure (specify how it's measured, e.g., mmHg). Unit of Measure: mmHg.

Variation in Adherence to the Mediterranean Diet

时间窗: 2 YEARS

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

次要结局

  • Adherence to Medication(2 YEARS)
  • Emergency Room Attendances(2 YEARS)
  • Cost Analysis(2 YEARS)
  • Healthcare Organization 1(2 years)
  • Healthcare Organization 3(2 years)
  • Healthcare Organization 5(2 years)
  • Change in Patient Risk Factors(2 YEARS)
  • Healthcare Organization 2(2 yeras)
  • Patient Prognosis(2 YEARS)
  • Healthcare Organization 4(2 yeras)
  • Lab samples results(2 years)

研究者

发起方
Jose Seijas Amigo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jose Seijas Amigo

PhD MS Pharmacy. Head of Clinical Trial Unit of Cardiology

Hospital Clinico Universitario de Santiago

研究点 (6)

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