Autonomic Failure Patients for RNA Blood Sampling

Identification of Autonomic Failure Patients, Controls and Blood Sampling for Pilot Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00742586

Enrollment

Registered

2008-08-27

Start date

2008-07-31

Completion date

2009-02-28

Last updated

2016-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

Yes

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

Countries

United States

Outcome results