Clinical trial NCT06952062: Identification and Validation of a Prediction Model for CARDIOvascular Events
Official title: Identification and Validation of a Prediction Model for CARDIOvascular Events in Patients With Multiple COMorbidities (CARDIO-COM)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular Diseases
Venous thromboembolism
Cancer
Bleeding
Risk Assessment Model
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients already affected by at least two pathologies at the time of the visit, prospectively recruited at the time of the first outpatient visit at the U.O.S.D. Percorso Trombosi of the I.R.C.C.S. Fondazione Policlinico Universitario Agostino Gemelli in Rome.

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.


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.

Primary outcomes:
measure: Major Cardiovascular Events
timeFrame: 10 years
measure: Major Limbs Events
timeFrame: 10 years
measure: Venous Thromboembolism
timeFrame: 10 years
Secondary outcomes:
measure: Venous thromboembolism
timeFrame: 10 years
measure: Bleeding
timeFrame: 10 years
measure: Death
timeFrame: 10 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Roberto Pola
role: PRINCIPAL_INVESTIGATOR
References: