Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421363
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-04-24
Brief Title:
Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease
Sponsor:
Jose Seijas Amigo
Organization:
Hospital Clinico Universitario de Santiago
Study Overview
Official Title:
Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPRICI
Brief Summary:
11 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
12 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 21 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
22 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 31 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
12 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 21 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
22 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 31 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None