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Clinical Trials/NCT03001284
NCT03001284
Unknown
Not Applicable

Multiple Sclerosis Produces Cardiovascular Subclinical Dysfunction

Carol Davila University of Medicine and Pharmacy0 sites103 target enrollmentOctober 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Carol Davila University of Medicine and Pharmacy
Enrollment
103
Primary Endpoint
Left ventricle systolic dysfunction - by echocardiography
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
December 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Carol Davila University of Medicine and Pharmacy
Responsible Party
Principal Investigator
Principal Investigator

Raluca Mincu

Dr

Carol Davila University of Medicine and Pharmacy

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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;
  • and difficult acoustic window

Outcomes

Primary Outcomes

Left ventricle systolic dysfunction - by echocardiography

Time Frame: 1 year

Left ventricular diastolic function - by echocardiography

Time Frame: 1 year

arterial function - by vascular echography

Time Frame: 1 year

Right ventricle systolic dysfunction- by echocardiography

Time Frame: 1 year

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