Multiple SclerosisNCT03001284
Multiple Sclerosis Produces Cardiovascular Subclinical Dysfunction
An observational study of Multiple Sclerosis, run by Carol Davila University of Medicine and Pharmacy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- age between 18 and 65 years;
- patients with confirmed MS diagnosis, both newly diagnosed or already under immunomodulatory treatment;
- informed consent signed.
Who cannot join
- 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
About this study
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
- Being tested
- NO intervention
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis patients | patients with confirmed multiple sclerosis, diagnosed according to the revised McDonald's criteria Receives: Other: NO intervention | |
| Control subjects | control subjects, matched for age, gender, and presence of cardiovascular risk factors Receives: Other: NO intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricle systolic dysfunction - by echocardiography
Measured: 1 year
Right ventricle systolic dysfunction- by echocardiography
Measured: 1 year
Left ventricular diastolic function - by echocardiography
Measured: 1 year
arterial function - by vascular echography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startOct 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Davila University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raluca Mincu, Carol Davila University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001284
- Sponsor's protocol ID
- UMFCD-141531-RM
- Status last verified
- Dec 2016
- First submitted
- 8 Dec 2016
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Sclerosis Produces Cardiovascular Subclinical Dysfunction
- ClinicalTrials.gov ID
- NCT03001284
- Acronym / sponsor ID
- UMFCD-141531-RM
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Carol Davila University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis patients | – | Other: NO interventionpatients with confirmed multiple sclerosis, diagnosed according to the revised McDonald's criteria |
| Control subjects | – | Other: NO interventioncontrol subjects, matched for age, gender, and presence of cardiovascular risk factors |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- age between 18 and 65 years;
- patients with confirmed MS diagnosis, both newly diagnosed or already under immunomodulatory treatment;
- informed consent signed.
Key exclusion criteria (8 listed)
- MS treated with mitoxantrone;
- patients with known cardiovascular disease;
- presence of other neurological conditions;
- any renal, pulmonary, hepatic or hematological disease;
- diabetes mellitus;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO intervention | Other | Control subjects, Multiple sclerosis patients |
Primary outcome
Left ventricle systolic dysfunction - by echocardiography
Time frame: 1 year
Right 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Carol Davila University of Medicine and Pharmacy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricle systolic dysfunction - by echocardiography (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2016.