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| Sponsors and Collaborators: |
Vanderbilt University Western Michigan University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00742586 |
Purpose
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
| Condition |
|---|
|
Pure Autonomic Failure Multiple System Atrophy Parkinson's Plus Syndromes |
| Study Type: | Observational |
| Official Title: | Identification of Autonomic Failure Patients, Controls and Blood Sampling for Pilot Study |
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | August 2010 |
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| Ages Eligible for Study: | 50 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
Inclusion Criteria for patients:
Inclusion Criteria for controls:
Exclusion Criteria:
Contacts and Locations| Contact: Bonnie K Black, BSN | bonnie.black@vanderbilt.edu |
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Bonnie K Black, RSN bonnie.black@vanderbilt.edu | |
| Principal Investigator: | David Robertson, MD | Vanderbilt University |
More Information
| Responsible Party: | Vanderbilt University Medical Center ( David Robertson, M.D. ) |
| Study ID Numbers: | 080373 |
| Study First Received: | August 25, 2008 |
| Last Updated: | August 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00742586 |
| Health Authority: | United States: Institutional Review Board |
|
Gene Expression Changes in Blood Cells RNA Pure Autonomic Failure Multiply System Atrophy Parkinson's Plus |
|
Pathological Conditions, Anatomical Multiple system atrophy Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Autonomic Nervous System Diseases Multiple System Atrophy Parkinson Disease Movement Disorders Atrophy Parkinsonian Disorders |
|
Pathologic Processes Disease Syndrome Nervous System Diseases |
