Autonomic Failure Patients for RNA Blood Sampling

NCT ID: NCT00742586

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-02-28

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.

Conditions

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

Eligibility Criteria

Inclusion Criteria

• 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

• Absence of neurological disorder
• age between 50 - 75 years
• Male or female
• Able and willing to provide consent

Exclusion Criteria

• inability to provide consent

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Western Michigan University

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

David Robertson

Professor of Medicine, Pharmacology and Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Robertson, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

080373

Identifier Type: -

Identifier Source: org_study_id