Survey on Cardiovascular Events in Patients With Metaboli... | NCT02311270

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

NCT02311270

Sponsor

University of South Florida

Status

Completed

Last Update Posted

Sep 23, 2016Estimated

Enrollment

106Actual

Phase

Not provided

Conditions

Metabolic Disorders

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Jun 2016Actual

First Submitted Date

Sep 12, 2014

First Submission Date that Met QC Criteria

Dec 4, 2014

First Posted Date

Dec 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2016

Last Update Posted Date

Sep 23, 2016Estimated

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess how many patients with metabolic disorders are on chronic carnitine supplementation.		Up to one year from study activation.

Secondary Outcomes

Measure	Description	Time Frame
Assess how many patients who are on chronic carnitine supplementation have experienced a cardiovascular event.		Up to one year from study activation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients enrolled in the NAMDC portion of the RDCRN Contact Registry

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amel Karaa, MD	Massachusetts General Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of South Florida		Tampa	Florida	33612	United States

Label	URL
Rare Diseases Clinical Research Network NAMDC page	View source

Condition Browse Module

MeSH Terms

ID	Term
D008659	Metabolic Diseases

Ancestor Terms

ID	Term
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided