Identification and Validation of a Prediction Model for CARDIOvascular Events

NCT ID: NCT06952062

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2037-05-02

Brief Summary

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.

Conditions

Cardiovascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Pola

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, , Italy

Countries

Italy

Other Identifiers

7517

Identifier Type: -

Identifier Source: org_study_id