Multiple Sclerosis Produces Cardiovascular Subclinical Dysfunction

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

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: NO intervention

• Study Type: Observational
• Enrollment (Actual): 103

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

te investigators enrolled prospectively patients with confirmed multiple sclerosis, diagnosed according to the revised McDonald's criteria[8], and control subjects, matched for age, gender, and presence of cardiovascular risk factors.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Left ventricle systolic dysfunction - by echocardiography	1 year
Right ventricle systolic dysfunction- by echocardiography	1 year
Left ventricular diastolic function - by echocardiography	1 year
arterial function - by vascular echography	1 year

Collaborators and Investigators

• Sponsor: Carol Davila University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: December 8, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (Estimate): December 23, 2016

Study Record Updates

• Last Update Posted (Estimate): December 23, 2016
• Last Update Submitted That Met QC Criteria: December 20, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: UMFCD-141531-RM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO