Impact of Assessment and Management of Comorbidities in Internal Medicine on Cardiovascular Risk

NCT ID: NCT06204549

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-21
• Study Completion Date: 2027-11-21

Brief Summary

The aim of assessing and managing cardiovascular risk is to avoid, limit or delay cardiovascular morbidity and mortality. Planned internal medicine hospitalization is developed around the management of cardiovascular risk in patients at high cardiovascular risk, whether in primary prevention or secondary prevention.

During planned hospitalization, patients benefit from comprehensive, personalized and adapted care for their comorbidities and their CVRF (cardiovascular risk factors).

This study will make it possible to evaluate this overall course of multidisciplinary management of comorbidities of patients at high cardiovascular risk.

Detailed Description

The aim of assessing and managing cardiovascular risk is to avoid, limit or delay cardiovascular morbidity and mortality. Planned internal medicine is developed around the management of cardiovascular risk in patients at high cardiovascular risk, whether in primary prevention patients, combining several cardiovascular risk factors CVRF (arterial hypertension, metabolic syndrome, diabetes, dyslipidemia, etc.), or patients in secondary prevention who have several CVRFs and have already had a major cardiovascular event such as ischemic heart disease, heart failure.

During scheduled hospitalization, patients benefit from comprehensive care. Additional examinations include measurement of blood pressure, cardiac ultrasound, vascular Dopplers, usual biological assessment (lipid, glycemic, renal, iron assessment, CRP), and on a case-by-case basis, ventilatory polygraphy to screen for obstructive sleep apnea hypopnea syndrome, pulmonary function tests if the patient is a smoker to screen for chronic obstructive pulmonary disease, coronary function test to screen for ischemic heart disease if indicated. Comorbidities are thus identified and summarized, and patients benefit from personalized and adapted care for their comorbidities and CVRFs.

Cardiovascular risk reduction strategy programs targeting high-risk patients are essential and their evaluation is necessary.This study will make it possible to evaluate this overall course of multidisciplinary management of comorbidities in patients at high cardiovascular risk in internal medicine.

The innovative nature of the project is the possibility to cross-reference the comorbidities and the cardiovascular and metabolic data of these patients at high cardiovascular risk with their evolving risk level over time. This will also make it possible to highlight which markers are the most effective to better stratify cardiovascular risk, or even consider personalized phenotyping. The coexistence of all these parameters within the same database represents a unique opportunity to study their respective influences in a population of patients at high cardiovascular risk.

Conditions

Adverse Cardiac Event; Major Adverse Cardiac Events

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Comorbidities screening and management

Group Type: OTHER

Screening and management of cormobidities

Intervention Type: OTHER

During the routine care assessment and as part of the research, patients will :

• Fill in cardiovascular risk assessment score: Life's simple 7
• Provide an additional blood sample (1 dry tube of 7 mL and 1 heparin tube of 7 mL) during their biological testing. These samples will be used for lipoprotein (a) testing and biological collection.

After hospital discharge, patients will be contacted by telephone at 3 and 12 months for re-evaluation and will fill in the Life's simple 7 score. Prior to this contact, patients will have biological tests as prescribed just before hospital discharge (including blood ionogram, creatinine, liver assessment, lipid assessment (LDL, HDL, triglycerides), fasting blood sugar test, A1C test, urinary albumin/creatinine ratio, protein/ urinary creatinine ratio). They will weigh themselves and take blood pressure self-measurements over 3 days.

Interventions

Screening and management of cormobidities

During the routine care assessment and as part of the research, patients will :

• Fill in cardiovascular risk assessment score: Life's simple 7
• Provide an additional blood sample (1 dry tube of 7 mL and 1 heparin tube of 7 mL) during their biological testing. These samples will be used for lipoprotein (a) testing and biological collection.

After hospital discharge, patients will be contacted by telephone at 3 and 12 months for re-evaluation and will fill in the Life's simple 7 score. Prior to this contact, patients will have biological tests as prescribed just before hospital discharge (including blood ionogram, creatinine, liver assessment, lipid assessment (LDL, HDL, triglycerides), fasting blood sugar test, A1C test, urinary albumin/creatinine ratio, protein/ urinary creatinine ratio). They will weigh themselves and take blood pressure self-measurements over 3 days.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• High-Risk Cardiovascular patients either receiving:

• Primary prevention because they have never had a cardiovascular event but have several cardiovascular risk factors such as high blood pressure particularly resistant, metabolic syndrome, diabetes , dyslipidemia, metabolic steatosis
• Or secondary prevention because they have already had a major cardiovascular event such as ischemic heart disease, heart failure
• Aged 18 and over
• Patient benefiting from comorbidities assessment during their planned hospitalization in the internal medicine department.

Exclusion Criteria

• Patient refusal
• Subject not registered in social security system
• Pregnant or breastfeeding woman
• Patient unable to give their informed consent, protected adult, vulnerable people
• Subject deprived of liberty by judicial or administrative decision

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

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Camille ROUBILLE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

University Hospital

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Fanny CARDON

Role: CONTACT

fanny-cardon@chu-montpellier.fr

0033 4 67 33 08 24

Facility Contacts

Camille ROUBILLE, DR

Role: primary

Other Identifiers

2023-A00012-43

Identifier Type: REGISTRY

Identifier Source: secondary_id

RECHMPL22_0390

Identifier Type: -

Identifier Source: org_study_id