Multiple Sclerosis Produces Cardiovascular Subclinical Dysfunction

NCT03001284 | Unknown

• 1 other identifier: UMFCD-141531-RM
• Study Type: observational
• Target: 103
• Locations: 0 countries
• Sites: N/A

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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

Interventions

NO intervention OTHER

Control subjects; Multiple sclerosis patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• MS treated with mitoxantrone;
• patients with known cardiovascular disease;
• presence of other neurological conditions;
• any renal, pulmonary, hepatic or hematological disease;
• diabetes mellitus;
• any degree of arterial hypertension;
• pregnancy;
• and difficult acoustic window

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 23, 2016
• Study Start: October 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 23, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share