Clinical trial NCT00742586: Autonomic Failure Patients for RNA Blood Sampling
Official title: Identification of Autonomic Failure Patients, Controls and Blood Sampling for Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Western Michigan University
First posted: 2008-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David Robertson, MD
role: PRINCIPAL_INVESTIGATOR
References: