Impact van beoordeling en beheer van comorbiditeiten in de interne geneeskunde op het cardiovasculaire risico (COMMEDCARDIO)
Impact van het Bilan en de prijs voor comorbiditeiten in de interne geneeskunde op het cardiovasculaire risico
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Montpellier, Frankrijk
- University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
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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
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Aged 18 and over
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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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: Screening en behandeling van comorbiditeiten
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During the routine care assessment and as part of the research, patients will :
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Screening and management of comorbidities effect on cardiovascular risk factors
Tijdsspanne: 3 months after enrollment
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Screening and management of comorbidities effect on cardiovascular risk factors
Tijdsspanne: 12 months after enrollment
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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
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Screening and management of comorbidities effect on blood pressure
Tijdsspanne: 3 and 12 months after enrollment
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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
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Screening and management of comorbidities effect on patient's weight
Tijdsspanne: 3 and 12 months after enrollment
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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
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Screening and management of comorbidities effect on the balance of cholesterol
Tijdsspanne: 3 and 12 months after enrollment
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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
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Screening and management of comorbidities effect on tobacco consumption
Tijdsspanne: 3 and 12 months after enrollment
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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
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Screening and management of comorbidities effect on the balance of blood sugar level
Tijdsspanne: 3 and 12 months after enrollment
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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
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Screening and management of comorbidities effect on A1C level
Tijdsspanne: 3 and 12 months after enrollment
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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
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Cardivascular events incidence
Tijdsspanne: 12 months after enrollment
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Description of the incidence of cardiovascular events including cardiovascular mortality. |
12 months after enrollment
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Initial participant's comorbidities
Tijdsspanne: At enrollment
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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
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C-reactive protein levels
Tijdsspanne: At enrollment
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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
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Lipoprotein a levels
Tijdsspanne: At enrollment
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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
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Camille ROUBILLE, MD, University Hospital, Montpellier
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Hart-en vaatziekten
- Kwaliteit, toegang en evaluatie van de gezondheidszorg
- Onderzoekstechnieken
- Epidemiologische methoden
- Diagnostische technieken en procedures
- Diagnose
- Gegevensverzameling
- Evaluatiemechanismen voor gezondheidszorg
- Kwaliteit van de gezondheidszorg
- Volksgezondheid
- Milieu en volksgezondheid
- Gezondheidsdiensten
- Gezondheidszorgfaciliteiten personeel en diensten
- Preventieve gezondheidsdiensten
- Diagnostische diensten
- Gezondheidsenquêtes
- Enquêtes en vragenlijsten
- Public Health Practice
- Massa -screening
Andere studie-ID-nummers
- RECHMPL22_0390
- 2023-A00012-43 (Register-ID: ID-RCB)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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