Clinical trial NCT06204549: Impact of Assessment and Management of Comorbidities in Internal Medicine on Cardiovascular Risk
Official title: Impact du Bilan et de la Prise en Charge Des comorbidités en médecine Interne Sur le Risque Cardiovasculaire
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adverse Cardiac Event
Major Adverse Cardiac Events
Keywords: Cardiovascular Risk
Comorbidities
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Screening and management of comorbidities effect on cardiovascular risk factors
timeFrame: 3 months after enrollment
Secondary outcomes:
measure: Screening and management of comorbidities effect on cardiovascular risk factors
timeFrame: 12 months after enrollment
measure: Screening and management of comorbidities effect on blood pressure
timeFrame: 3 and 12 months after enrollment
measure: Screening and management of comorbidities effect on patient's weight
timeFrame: 3 and 12 months after enrollment
measure: Screening and management of comorbidities effect on the balance of cholesterol
timeFrame: 3 and 12 months after enrollment
measure: Screening and management of comorbidities effect on tobacco consumption
timeFrame: 3 and 12 months after enrollment
measure: Screening and management of comorbidities effect on the balance of blood sugar level
timeFrame: 3 and 12 months after enrollment
measure: Screening and management of comorbidities effect on A1C level
timeFrame: 3 and 12 months after enrollment
measure: Cardivascular events incidence
timeFrame: 12 months after enrollment
measure: Initial participant's comorbidities
timeFrame: At enrollment
measure: C-reactive protein levels
timeFrame: At enrollment
measure: Lipoprotein a levels
timeFrame: At enrollment
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Camille ROUBILLE, MD
role: PRINCIPAL_INVESTIGATOR
References: