Multiple Sclerosis Produces Cardiovascular Subclinical Dysfunction

• Conditions: Multiple Sclerosis
• Interventions: Other: NO intervention

• Registration Number: NCT03001284
• Lead Sponsor: Carol Davila University of Medicine and Pharmacy

Brief Summary

Multiple sclerosis (MS), debilitating disease involving primarily the central nervous system, may cause cardiovascular dysfunction, due to autonomous nervous system dysfunction, physical invalidity, increased oxidative stress, and systemic inflammatory status, but the detailed mechanisms are not elucidated. The investigators aimed to assess left and right ventricular (LV and RV) function, left atrial (LA) function, arterial function, and atrial-ventricular-arterial coupling in patients with MS, compared to control subjects. LV systolic and diastolic function and RV function were assessed by 2D- and 3D- echocardiography, tissue Doppler, and speckle tracking echocardiography. LA function was assessed by LA volume index and LA strain. Arterial remodeling and stiffness were assessed by intima media-thickness, pulse wave velocity, and parameters of wave intensity and endothelial function

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-20
• Last Update Submitted: 2016-12-20
• Study First Posted: 2016-12-23
• Last Update Posted: 2016-12-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

1. age between 18 and 65 years;
2. patients with confirmed MS diagnosis, both newly diagnosed or already under immunomodulatory treatment;
3. informed consent signed.

Exclusion Criteria

1. MS treated with mitoxantrone;
2. patients with known cardiovascular disease;
3. presence of other neurological conditions;
4. any renal, pulmonary, hepatic or hematological disease;
5. diabetes mellitus;
6. any degree of arterial hypertension;
7. pregnancy;
8. and difficult acoustic window

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control subjects	NO intervention	control subjects, matched for age, gender, and presence of cardiovascular risk factors
Multiple sclerosis patients	NO intervention	patients with confirmed multiple sclerosis, diagnosed according to the revised McDonald's criteria

Primary Outcome Measures

Name	Time	Method
Left ventricle systolic dysfunction - by echocardiography	1 year
Left ventricular diastolic function - by echocardiography	1 year
arterial function - by vascular echography	1 year
Right ventricle systolic dysfunction- by echocardiography	1 year