Subtle Myocardial Deformation Abnormalities in Asymptomat... | NCT02505412

Studies
Subtle Myocardial Deformation Abnormalities in Asymptomatic Nf-1 Patients

NCT02505412

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Jul 22, 2015Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Neurofibromatosis Type 1

Interventions

Not provided

Countries

Not provided

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

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jul 16, 2015

First Submission Date that Met QC Criteria

Jul 21, 2015

First Posted Date

Jul 22, 2015Estimated

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

Jul 21, 2015

Last Update Posted Date

Jul 22, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

michal roll, michal roll (telavivsmo), Tel-Aviv Sourasky Medical CenterPrincipal Investigator

Lead Sponsor

Tel-Aviv Sourasky Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
myocardial deformation indices as measured in percentage (change of original length)		up to 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

asymptomatic NF1 patients
aged 0-17y and 11 months

Exclusion Criteria:

clinical heart failure,
history of cardiovascular disease
chronic renal insufficiency

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Consecutive asymptomatic NF1 patients, aged 0-17y and 11 month, who will visit the investigators' Neurofibromatosis tertiary outpatients clinics

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D009456	Neurofibromatosis 1

Ancestor Terms

ID	Term
D017253	Neurofibromatoses
D009455	Neurofibroma
D018317	Nerve Sheath Neoplasms
D009380	Neoplasms, Nerve Tissue

Browse Leaves

Not provided

Browse Branches

Not provided