Subtle Myocardial Deformation Abnormalities in Asymptomatic Nf-1 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02505412
Recruitment Status : Unknown
Verified July 2015 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 22, 2015
Last Update Posted : July 22, 2015
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

Brief Summary:
Subtle myocardial deformation abnormalities in asymptomatic nf-1 patients: is cardiac screening needed?

Condition or disease
Neurofibromatosis Type 1

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of Subtle Myocardial Deformation Abnormalities in Asymptomatic Nf-1 Patients: is Cardiac Screening Needed?
Study Start Date : October 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Primary Outcome Measures :
  1. myocardial deformation indices as measured in percentage (change of original length) [ Time Frame: up to 2 years ]

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Consecutive asymptomatic NF1 patients, aged 0-17y and 11 month, who will visit the investigators' Neurofibromatosis tertiary outpatients clinics

Inclusion Criteria:

  • asymptomatic NF1 patients
  • aged 0-17y and 11 months

Exclusion Criteria:

  • clinical heart failure,
  • history of cardiovascular disease
  • chronic renal insufficiency

Responsible Party: michal roll, michal roll (telavivsmo), Tel-Aviv Sourasky Medical Center Identifier: NCT02505412     History of Changes
Other Study ID Numbers: TLV-0212-15
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Neurofibromatosis 1
Genetic Diseases, Inborn
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms