Autonomic Failure Patients for RNA Blood Sampling

Multiple System Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742586
• Other study ID #: 080373
• Status: Completed
• Phase: N/A
• First received: August 25, 2008
• Last updated: October 14, 2016
• Start date: July 2008
• Est. completion date: February 2009

Study information

• Verified date: October 2016
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Parkinson's Plus Syndromes
• Pure Autonomic Failure
• Shy-Drager Syndrome

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Western Michigan University

Country where clinical trial is conducted

United States,