Cardiovascular DiseasesCARDIO-COMNCT06952062
Identification and Validation of a Prediction Model for CARDIOvascular Events
An observational study of Cardiovascular Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Background: Cardiovascular risk stratification is a cornerstone of modern preventive medicine, particularly in patients with multiple comorbidities, where risk estimation is inherently complex. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 2,400 participants
- Where
- 1 siteItaly
- Study dates
- 3 Apr 2025to 2 May 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Unable or unwilling to perform follow-up visits.
- Life expectancy < 3 months.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
About this study
Official title: Identification and Validation of a Prediction Model for CARDIOvascular Events in Patients With Multiple COMorbidities (CARDIO-COM)
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.
Read more
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
- Keywords
- Cardiovascular Diseases, Venous thromboembolism, Cancer, Bleeding, Risk Assessment Model
- Medical subject headings
- Cardiovascular Diseases, Venous Thromboembolism, Neoplasms, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Cardiovascular Events
acute coronary syndrome, coronary revascularization, stroke
Measured: 10 years
Major Limbs Events
acute limb ischemia of the lower limbs or need for revascularization of the lower limbs
Measured: 10 years
Venous Thromboembolism
Deep vein thrombosis of the lower limbs or Pulmonary embolism
Measured: 10 years
Secondary outcomes (3)
Venous thromboembolism
Venous thromboembolism in unusual sites (i.e., upper limb, splanchnic, cerebral, ovarian, atrial)
Measured: 10 years
Bleeding
Major and non-major clinically relevant bleeding events
Measured: 10 years
Death
Mortality for any cause
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start3 Apr 2025
- Primary completion2 May 2037 (estimated)
- Study completion2 May 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Pola, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952062
- Sponsor's protocol ID
- 7517
- Acronym
- CARDIO-COM
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Validation of a Prediction Model for CARDIOvascular Events in Patients With Multiple COMorbidities (CARDIO-COM)
- ClinicalTrials.gov ID
- NCT06952062
- Acronym / sponsor ID
- CARDIO-COM / 7517
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular Diseases, Venous thromboembolism, Cancer, Bleeding, Risk Assessment Model
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 2 May 2037 (estimated)
- Study completion
- 2 May 2037 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Unable or unwilling to perform follow-up visits.
- Life expectancy < 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Cardiovascular Events
Time frame: 10 years
acute coronary syndrome, coronary revascularization, stroke
Major Limbs Events
Time frame: 10 years
acute limb ischemia of the lower limbs or need for revascularization of the lower limbs
Venous Thromboembolism
Time frame: 10 years
Deep vein thrombosis of the lower limbs or Pulmonary embolism
3 secondary outcomes
Venous thromboembolism
Time frame: 10 years
Bleeding
Time frame: 10 years
Death
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Pola principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Cardiovascular Events (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.