We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autonomic Failure Patients for RNA Blood Sampling

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00742586
First Posted: August 27, 2008
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Western Michigan University
Information provided by (Responsible Party):
David Robertson, Vanderbilt University
  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

Resource links provided by NLM:


Further study details as provided by David Robertson, Vanderbilt University:

Enrollment: 30
Study Start Date: July 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742586


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Western Michigan University
Investigators
Principal Investigator: David Robertson, MD Vanderbilt University Medical Center
  More Information

Responsible Party: David Robertson, Professor of Medicine, Pharmacology and Neurology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00742586     History of Changes
Other Study ID Numbers: 080373
First Submitted: August 25, 2008
First Posted: August 27, 2008
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by David Robertson, Vanderbilt University:
Gene Expression Changes in Blood Cells
RNA
Pure Autonomic Failure
Multiply System Atrophy
Parkinson's Plus

Additional relevant MeSH terms:
Atrophy
Multiple System Atrophy
Shy-Drager Syndrome
Pure Autonomic Failure
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases