Impact of Assessment and Management of Comorbidities in Internal Medicine on Cardiovascular Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patient refusal
Subject not registered in social security system
Pregnant or breastfeeding woman
Patient unable to give their informed consent, protected adult, vulnerable people
Trial design
Design model
Single group
Treatments tested in this trial
Screening and management of cormobidities
Other interventionDuring 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.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Comorbidities screening and managementOther 1 intervention
Trial outcomes
Primary outcomes
1
Screening and management of comorbidities effect on cardiovascular risk factors
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.
Time frame
3 months after enrollmentSecondary outcomes
1
Screening and management of comorbidities effect on cardiovascular risk factors
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.
Time frame
12 months after enrollment2
Screening and management of comorbidities effect on blood pressure
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.
Time frame
3 and 12 months after enrollment3
Screening and management of comorbidities effect on patient's weight
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.
Time frame
3 and 12 months after enrollment4
Screening and management of comorbidities effect on the balance of cholesterol
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.
Time frame
3 and 12 months after enrollmentSponsors and contacts
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Source ClinicalTrials.gov