Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06204549

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Adverse Cardiac Event Cardiovascular Diseases Major Adverse Cardiac Events

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Montpellier, France

Location status: Recruiting

Location contact

Camille ROUBILLE

PRINCIPAL_INVESTIGATOR

Camille ROUBILLE, DR

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening and management of cormobidities

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.

Primary outcomes

  1. Screening and management of comorbidities effect on cardiovascular risk factors

    Time frame: 3 months after enrollment

    Effect of comorbidities screening and management on cardiovascular risk factors in patients at high-risk of a cardiovascular event.

    The life's simple 7 score will be used at enrollment and 3 months afterward. The score includes four modifiable behaviors (smoking, weight, healthy/unhealthy eating diet and physical activity) and three biometric measures (blood pressure, cholesterol and blood sugar level). These seven factors are classified into three categories: ideal, intermediate and poor. Life's Simple 7 summary score ranges from 0 to a maximum of 14 points, with a higher score indicating healthier status.

Secondary outcomes

  1. Screening and management of comorbidities effect on cardiovascular risk factors

    Time frame: 12 months after enrollment

    Effect of comorbidities screening and management on cardiovascular risk factors in patients at high-risk of a cardiovascular event.

    The life's simple 7 score will be used at 12 months after enrollment. The score includes four modifiable behaviors (smoking, weight, healthy/unhealthy eating diet and physical activity) and three biometric measures (blood pressure, cholesterol and blood sugar level). These seven factors are classified into three categories: ideal, intermediate and poor. Life's Simple 7 summary score ranges from 0 to a maximum of 14 points, with a higher score indicating healthier status.

  2. Screening and management of comorbidities effect on blood pressure

    Time frame: 3 and 12 months after enrollment

    Effect of comorbidities screening and management on the evolution of cardiovascular risk factor "blood pressure" 3 and 12 months after hospital discharge compared to hospitalization.

    Measurement method: Holter blood pressure measurement during hospitalization, and self-measured blood pressure average over 3 days at 3 and 12 months after hospitalization using cuff device for self-measurement.

  3. Screening and management of comorbidities effect on patient's weight

    Time frame: 3 and 12 months after enrollment

    Effect of comorbidities screening and management on the evolution of cardiovascular risk factor "weight" at 3 and 12 months after hospital discharge compared to hospitalization.

    The patient's weight will be measured using a weighing scale.

  4. Screening and management of comorbidities effect on the balance of cholesterol

    Time frame: 3 and 12 months after enrollment

    Effect of comorbidities screening and management on cardiovascular risk factor "cholesterol" by evaluating the evolution at 3 and 12 months after hospital discharge compared to hospitalization of biological tests: HDL (high-density lipoprotein), LDL(low-density lipoprotein) and triglycerides.

  5. Screening and management of comorbidities effect on tobacco consumption

    Time frame: 3 and 12 months after enrollment

    Effect of comorbidities screening and management on the evolution of cardiovascular risk factor "tobacco consumption" (weaned or still acive,level of consumption) at 3 and 12 months after hospital discharge compared to hospitalization.

  6. Screening and management of comorbidities effect on the balance of blood sugar level

    Time frame: 3 and 12 months after enrollment

    Effect of comorbidities screening and management on cardiovascular risk factor "blood sugar" by evaluating the evolution of fasting blood sugar test results at 3 and 12 months after hospital discharge compared to hospitalization.

  7. Screening and management of comorbidities effect on A1C level

    Time frame: 3 and 12 months after enrollment

    Effect of comorbidities screening and management on the evolution of A1C test results at 3 and 12 months after hospital discharge compared to hospitalization in diabetic patients.

  8. Cardivascular events incidence

    Time frame: 12 months after enrollment

    Description of the incidence of cardiovascular events including cardiovascular mortality.

  9. Initial participant's comorbidities

    Time frame: At enrollment

    Exploration of demographic characteristics and initial comorbidities as factors associated with the evolution of cardiovascular risk factors and markers, for cardiovascular risk stratification purpose.

    Charlson Comorbidity Index (CCI) will be used at enrollment.The Index assesses comorbidity level by taking into account both the number and severity of 19 pre-defined comorbid conditions. It provides a weighted score of a patient's comorbidities which can be used to predict short term and long-term outcomes such as function, hospital length of stay and mortality rates.The total score in the CCI is derived by summing the assigned weights of all comorbid conditions presented by the patient. Higher scores indicate a more severe condition and consequently, a worse prognosis.

  10. C-reactive protein levels

    Time frame: At enrollment

    Exploration of C-reactive protein (CRP) levels as an associated factor with the evolution of cardiovascular risk markers for cardiovascular risk stratification purpose

  11. Lipoprotein a levels

    Time frame: At enrollment

    Exploration of Lipoprotein a levels as an associated factor with the evolution of cardiovascular risk factors and markers for cardiovascular risk stratification purpose.

Study contacts

Contact information is provided by the study sponsor or research team.

Fanny CARDON

CONTACT

[email protected]

0033 4 67 33 08 24

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Impact du Bilan et de la Prise en Charge Des comorbidités en médecine Interne Sur le Risque Cardiovasculaire

Acronym: COMMEDCARDIO

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2024
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.