Autonomic Failure Patients for RNA Blood Sampling
Primary Purpose
Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Plus Syndromes
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Pure Autonomic Failure focused on measuring Gene Expression Changes in Blood Cells, RNA, Pure Autonomic Failure, Multiply System Atrophy, Parkinson's Plus
Eligibility Criteria
Inclusion Criteria for patients:
- 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
Inclusion Criteria for controls:
- Absence of neurological disorder
- age between 50 - 75 years
- Male or female
- Able and willing to provide consent
Exclusion Criteria:
- inability to provide consent
Sites / Locations
- Vanderbilt University Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00742586
First Posted
August 25, 2008
Last Updated
October 14, 2016
Sponsor
Vanderbilt University
Collaborators
Western Michigan University
1. Study Identification
Unique Protocol Identification Number
NCT00742586
Brief Title
Autonomic Failure Patients for RNA Blood Sampling
Official Title
Identification of Autonomic Failure Patients, Controls and Blood Sampling for Pilot Study
Study Type
Observational
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
Western Michigan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
Patients with one of the following autonomic problems will be recruited to participate in this study: multiple systems atrophy (MSA), pure autonomic failure (PAF) or Parkinson's Plus. The study consists of drawing 15 ml of whole blood for RNA. The blood is drawn in special collection tubes to stabilize the RNA material in the blood. The samples will be frozen and shipped to WMU for analysis.
The patients will also be asked to provide the current list of their medications, their age and the age when they were first diagnosed with their neurologic or autonomic disorder. This information will be de-identified and sent to the investigators at WMU as a limited data set.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Enrollment
30 (Actual)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for patients:
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
Inclusion Criteria for controls:
Absence of neurological disorder
age between 50 - 75 years
Male or female
Able and willing to provide consent
Exclusion Criteria:
inability to provide consent
Study Population Description
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
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Robertson, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
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Autonomic Failure Patients for RNA Blood Sampling
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