Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06421363
Other study ID # CORONARIA 1/2023
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT06013813 - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT05412927 - AngelMed Guardian® System PMA Post Approval Study
Completed NCT02750579 - Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes? N/A
Completed NCT04102410 - Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients N/A
Enrolling by invitation NCT03342131 - Serum Concentration of Wnt2 and Wnt4 in Patients With Acute Coronary Syndrome N/A
Recruiting NCT01218776 - International Survey of Acute Coronary Syndromes in Transitional Countries
Enrolling by invitation NCT04676100 - International CR Registry
Completed NCT03590535 - 5th Generation cTnT in ED ACS
Recruiting NCT05437900 - INSIGHTFUL-FFR Clinical Trial Phase 4
Completed NCT05551429 - Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
Terminated NCT04316481 - IDE-ALERTS Continued Access Study N/A
Active, not recruiting NCT04475380 - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting NCT04852146 - Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine.
Active, not recruiting NCT02892903 - In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes? N/A
Completed NCT04077229 - Piloting Text Messages to Promote Positive Affect and Physical Activity N/A
Not yet recruiting NCT02871622 - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM N/A
Completed NCT02944123 - Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR) Phase 3
Active, not recruiting NCT02922140 - The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit N/A
Terminated NCT02620202 - Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain