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Wpływ oceny i leczenia chorób współistniejących w chorobach wewnętrznych na ryzyko sercowo-naczyniowe (COMMEDCARDIO)

21 września 2026 zaktualizowane przez: University Hospital, Montpellier

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

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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

70

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Francja
      • Montpellier, Francja
        • University Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Inny: Badania przesiewowe i leczenie chorób współistniejących
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Screening and management of comorbidities effect on cardiovascular risk factors
Ramy czasowe: 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.
3 months after enrollment

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Screening and management of comorbidities effect on cardiovascular risk factors
Ramy czasowe: 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.
12 months after enrollment
Screening and management of comorbidities effect on blood pressure
Ramy czasowe: 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 and 12 months after enrollment
Screening and management of comorbidities effect on patient's weight
Ramy czasowe: 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.
3 and 12 months after enrollment
Screening and management of comorbidities effect on the balance of cholesterol
Ramy czasowe: 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.
3 and 12 months after enrollment
Screening and management of comorbidities effect on tobacco consumption
Ramy czasowe: 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.
3 and 12 months after enrollment
Screening and management of comorbidities effect on the balance of blood sugar level
Ramy czasowe: 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.
3 and 12 months after enrollment
Screening and management of comorbidities effect on A1C level
Ramy czasowe: 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.
3 and 12 months after enrollment
Cardivascular events incidence
Ramy czasowe: 12 months after enrollment

Description of the incidence of cardiovascular events including cardiovascular mortality.
12 months after enrollment
Initial participant's comorbidities
Ramy czasowe: 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.
At enrollment
C-reactive protein levels
Ramy czasowe: 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
At enrollment
Lipoprotein a levels
Ramy czasowe: 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.
At enrollment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University Hospital, Montpellier

Śledczy

  • Główny śledczy: Camille ROUBILLE, MD, University Hospital, Montpellier

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

21 maja 2024

Zakończenie podstawowe (Szacowany)

21 maja 2027

Ukończenie studiów (Szacowany)

21 listopada 2027

Daty rejestracji na studia

Pierwszy przesłany

2 stycznia 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 stycznia 2024

Pierwszy wysłany (Rzeczywisty)

12 stycznia 2024

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • RECHMPL22_0390
  • 2023-A00012-43 (Identyfikator rejestru: ID-RCB)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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