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临床试验/NCT06952062
NCT06952062进行中(未招募)不适用

Identification and Validation of a Prediction Model for CARDIOvascular Events in Patients With Multiple COMorbidities (CARDIO-COM)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2025年4月3日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,400
试验地点
1
主要终点
Major Cardiovascular Events

研究概览

简要总结

Background: Cardiovascular risk stratification is a cornerstone of modern preventive medicine, particularly in patients with multiple comorbidities, where risk estimation is inherently complex. Existing tools such as SCORE2 and the CUORE project provide important insights into cardiovascular risk but are limited in their ability to account for the interplay of multiple coexisting conditions.

Objective: The primary aim of this prospective cohort study is to develop and validate a novel cardiovascular risk prediction model specifically tailored for patients with at least two concomitant chronic diseases. Secondary objectives include comparing the predictive performance of the new model with that of SCORE2 and the CUORE project, and quantifying the incidence of venous thromboembolism (VTE), bleeding, and overall mortality in this high-risk population.

Methods: This is a prospective, monocentric, observational cohort study with an expected duration of 144 months. Patients ≥18 years with at least two of a predefined list of chronic conditions will be recruited at the Thrombosis Unit of Fondazione Policlinico Universitario A. Gemelli IRCCS. Clinical, laboratory, and instrumental data will be collected at baseline and during annual follow-up visits, for a maximum follow-up period of 10 years. Major cardiovascular events, VTE, bleeding, and mortality will be recorded. A Fine & Gray competing risks model will be applied for risk modeling, with subsequent validation in an independent cohort. Model discrimination and calibration will be evaluated using time-dependent ROC curves and calibration plots.

Expected Outcomes: The study aims to generate a robust and clinically applicable cardiovascular risk prediction model that better reflects the complexity of patients with multimorbidity. The model is expected to improve individualized prevention strategies and optimize resource allocation in clinical practice.

Ethical Considerations: The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Informed consent will be obtained from all participants.

详细描述

Introduction Cardiovascular risk assessment is of fundamental importance in medicine, especially given the high prevalence of cardiovascular diseases and their association with a wide range of comorbidities. Cardiovascular diseases are a major cause of morbidity and mortality worldwide, and correct risk assessment is essential for prevention, early diagnosis and optimal management of patients. Cardiovascular risk stratification allows physicians to identify high-risk subjects who could benefit from targeted preventive interventions, thus improving clinical outcomes and reducing healthcare costs associated with acute cardiovascular events.

Currently available cardiovascular risk assessment tools, such as SCORE2 and the CUORE project, represent significant steps towards preventive and personalized medicine. However, despite their usefulness, these scores have some intrinsic limitations that reduce their effectiveness in considering the entire spectrum of risk factors, especially in patients with multiple comorbidities.

SCORE2 (Systematic Coronary Risk Evaluation 2) is an evolution of the original SCORE model, developed to improve the estimation of cardiovascular risk in several European populations2. This tool takes into account variables such as age, sex, blood pressure, total cholesterol and cigarette smoking to calculate the 10-year risk of a fatal cardiovascular event. Despite the update compared to the previous model, SCORE2 continues to be based on a limited number of risk factors and may not accurately reflect the clinical complexity of patients with multiple conditions, such as diabetes, obesity, chronic kidney disease and other comorbidities.

The CUORE project, developed in Italy, aims to provide a cardiovascular risk assessment tool specific to the Italian population. It also uses traditional risk factors such as age, sex, blood pressure, cholesterol, diabetes and smoking to estimate the 10-year risk of major cardiovascular events, such as myocardial infarction and stroke. Although the CUORE project represents an important contribution to preventive medicine, its limitations are similar to those of SCORE2: a partial view of risk factors that does not always capture the complexity of patients with multiple comorbidities.

The importance of cardiovascular risk estimation lies in the possibility of adopting effective and personalized preventive strategies. However, the accuracy of these tools is crucial for the success of preventive measures. Comorbidities, such as diabetes mellitus, hypertension, dyslipidemia, obesity, chronic kidney disease and neoplastic diseases, are often present simultaneously in patients and can interact with each other, amplifying cardiovascular risk in a non-linear way. Current tools tend to consider these factors in isolation, failing to adequately represent the complex interaction between different comorbidities.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • History of at least two of the following conditions: arterial hypertension, dyslipidemia, type 2 diabetes mellitus, ischemic heart disease, heart failure with reduced or preserved ejection fraction, atrial fibrillation, cardiac valvular disease, cerebrovascular disease, obesity, chronic obstructive pulmonary disease, chronic kidney disease, neoplasia (except localized basal cell or squamous cell skin neoplasms), active or previous venous thromboembolism.
  • Age greater than 18 years.
  • Expression of Informed Consent.

排除标准

  • Unable or unwilling to perform follow-up visits.
  • Life expectancy < 3 months.

结局指标

主要结局

Major Cardiovascular Events

时间窗: 10 years

acute coronary syndrome, coronary revascularization, stroke

Major Limbs Events

时间窗: 10 years

acute limb ischemia of the lower limbs or need for revascularization of the lower limbs

Venous Thromboembolism

时间窗: 10 years

Deep vein thrombosis of the lower limbs or Pulmonary embolism

次要结局

  • Venous thromboembolism(10 years)
  • Bleeding(10 years)
  • Death(10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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