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Multiple Sclerosis Produces Cardiovascular Subclinical Dysfunction

NCT ID: NCT03001284

Last Updated: 2016-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Multiple sclerosis patients

patients with confirmed multiple sclerosis, diagnosed according to the revised McDonald's criteria

NO intervention

Intervention Type OTHER

Control subjects

control subjects, matched for age, gender, and presence of cardiovascular risk factors

NO intervention

Intervention Type OTHER

Interventions

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NO intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Carol Davila University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Raluca Mincu

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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UMFCD-141531-RM

Identifier Type: -

Identifier Source: org_study_id