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Survey on Cardiovascular Events in Patients With Metabolic Disease on Chronic Carnitine Supplementation

Sponsor
University of South Florida (Other)
Overall Status
Completed
CT.gov ID
NCT02311270
Collaborator
National Institutes of Health (NIH) (NIH)
106
Enrollment
1
Location
21
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to learn about the effects of long term carnitine use in patients with metabolic disorders and its potential relationship to cardiovascular events.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This online cross-sectional survey will examine the self-reported long-term carnitine use in patients with metabolic disorders and any potential relationship to cardiovascular events.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    106 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Survey on Cardiovascular Events in Patients With Metabolic Disease on Chronic Carnitine Supplementation
    Study Start Date :
    Sep 1, 2014
    Actual Primary Completion Date :
    Sep 1, 2015
    Actual Study Completion Date :
    Jun 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Assess how many patients with metabolic disorders are on chronic carnitine supplementation. [Up to one year from study activation.]

    Secondary Outcome Measures

    1. Assess how many patients who are on chronic carnitine supplementation have experienced a cardiovascular event. [Up to one year from study activation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Diagnosis of mitochondrial disease or any other metabolic disorder

    • Any age group

    • NAMDC or RDCRN registry participant

    Exclusion Criteria:

    • Inability to provide informed consent and complete survey

    • Lack of participation in NAMDC or RDCRN registry

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of South Florida Tampa Florida United States 33612

    Sponsors and Collaborators

    • University of South Florida
    • National Institutes of Health (NIH)

    Investigators

    • Study Chair: Amel Karaa, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of South Florida
    ClinicalTrials.gov Identifier:
    NCT02311270
    Other Study ID Numbers:
    • NAMDC7412
    First Posted:
    Dec 8, 2014
    Last Update Posted:
    Sep 23, 2016
    Last Verified:
    Sep 1, 2016
    Additional relevant MeSH terms:
    Metabolic Diseases

    Study Results

    No Results Posted as of Sep 23, 2016