Multiple Sclerosis Produces Cardiovascular Subclinical Dysfunction

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03001284
• Other study ID #: UMFCD-141531-RM
• Status: Active, not recruiting
• Phase: N/A
• First received: December 8, 2016
• Last updated: December 20, 2016
• Start date: October 2012
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Carol Davila University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ministry of Public Health
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 103
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• NO intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carol Davila University of Medicine and Pharmacy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricle systolic dysfunction - by echocardiography		1 year	No
Primary	Right ventricle systolic dysfunction- by echocardiography		1 year	No
Primary	Left ventricular diastolic function - by echocardiography		1 year	No
Primary	arterial function - by vascular echography		1 year	No