Autonomic Failure Patients for RNA Blood Sampling

NCT00742586 | Completed

• 1 other identifier: 080373
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify 15 patients with autonomic failure and obtain blood samples for RNA from those participants and 15 control subjects within the same age range. The stabilized blood samples, along with a limited data set, will be shipped to Western Michigan University where the actual laboratory analysis (a separate study) of the samples will take place. Unique genetic inscriptions, called gene expression signatures, are currently being identified for many diseases, including neurological diseases. The secondary goal of this study is to support the research being done at WMU and they try to look for MSA-specific signs are present in whole blood samples of MSA patients at late-stages of the disease. This is a pilot study that has a long term goal (through additional studies) a MSA-specific gene expression signature for the development of a diagnostic test for this disease that can be used in the future. Other patient groups with autonomic failure, characterized by significant drop in blood pressure on standing, will also be included in this study, to look for similar genetic inscriptions. This pilot study is expected to last for 2 years. The investigators at WMU will need some de-identified health Information about the subjects, including their age at diagnosis, age (when sample drawn) and list of their medications

Conditions

Pure Autonomic Failure; Multiple System Atrophy; Parkinson's Plus Syndromes

Keywords

Gene Expression Changes in Blood Cells; RNA; Pure Autonomic Failure; Multiply System Atrophy; Parkinson's Plus

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

15 patients with diagnosis of autonomic disorder characterized by orthostatic hypotension, Pure Autonomic Failure, Multiple System Atrophy or Parkinson's Plus. 15 controls without a neurological disorder

You may qualify if:

• presumed or probably diagnosis of autonomic disorder characterized by orthostatic hypotension
• age between 50 - 75 years
• Male or female
• Able and willing to provide consent
• Absence of neurological disorder
• age between 50 - 75 years
• Male or female
• Able and willing to provide consent

You may not qualify if:

• inability to provide consent

Sponsors & Collaborators

• Vanderbilt University: lead
• Western Michigan University: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pure Autonomic Failure; Multiple System Atrophy

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• David Robertson, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Pharmacology and Neurology

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 27, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

US (1)