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

NCT06204549 | Recruiting

• 2 other identifiers: RECHMPL22_03902023-A00012-43
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Cardiac Event; Major Adverse Cardiac Events

Keywords

Cardiovascular Risk; Comorbidities

Outcome Measures

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.

  3 months after enrollment

Secondary Outcomes (11)

• Screening and management of comorbidities effect on cardiovascular risk factors

  12 months after enrollment

• Screening and management of comorbidities effect on blood pressure

  3 and 12 months after enrollment

• Screening and management of comorbidities effect on patient's weight

  3 and 12 months after enrollment

• Screening and management of comorbidities effect on the balance of cholesterol

  3 and 12 months after enrollment

• Screening and management of comorbidities effect on tobacco consumption

  3 and 12 months after enrollment

Study Arms (1)

Comorbidities screening and management

OTHER

Other: Screening and management of cormobidities

Interventions

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.

Comorbidities screening and management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Mass Screening

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Camille ROUBILLE, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fanny CARDON

CONTACT

0033 4 67 33 08 24; fanny-cardon@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 12, 2024
• Study Start: May 21, 2024
• Primary Completion (Estimated): May 21, 2027
• Study Completion (Estimated): November 21, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-05

Locations

FR (1)