Venous Obstruction in Neurodegenerative Disorders Research Registry

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. Identifier: NCT01593358
Recruitment Status : Unknown
Verified May 2012 by Synergy Health Concepts, Inc..
Recruitment status was:  Recruiting
First Posted : May 8, 2012
Last Update Posted : May 8, 2012
Information provided by (Responsible Party):
Synergy Health Concepts, Inc.

Brief Summary:
To establish if there are venous obstructions in patients with neurodegenerative disorders

Condition or disease
Chronic Cerebral Spinal Venous Insufficiency

Detailed Description:
This research registry will observe the venous obstruction in neurodegenerative disorders. This will provide data that will allow researchers to classify abnormal valve and venous morphology, distinguish vessels which are more responsive to treatment, determine groups who respond more favorably to treatment, and overall evaluate the outcomes of venous angioplasty in various neurodegenerative disorders that involve venous obstruction.

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Venous Obstruction in Neurodegenerative Disorders Research Registry
Study Start Date : August 2011
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Human subjects will be approached for participation in this registry that are receiving or seeking medical care at Synergy Health Concepts, Inc.No individuals shall be excluded from participation in the Research Registry based on race, ethnicity, or gender.

Inclusion Criteria:

  • Ability to comprehend the nature of the study, including the risks and benefits and execute an informed consent
  • Males or Females between the ages of 18 and 90 years of age
  • Voluntary agreement to participate in the Venous Obstructions in Neurodegenerative Diseases Research Registry

Exclusion Criteria:

  • Any implantable/metallic objects that prevent subject from having a magnetic resonance imaging ( MRI/MRV) study
  • History of uncontrolled hypertension
  • Previous venous angioplasty treatment for Chronic cerebral spinal venous insufficiency
  • Special Populations. Special groups include, but are not limited to children, prisoners, pregnant women,fetuses, and cognitively impaired individuals who are unable to provide informed consent

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 identifier (NCT number): NCT01593358

Contact: Frances DeBarge-Igoe, RN (949) 221-0129

United States, California
Synergy Health Concepts, Inc. Recruiting
Newport Beach, California, United States, 92660
Contact: Frances Debarge-Igoe, RN    949-221-0129      
Principal Investigator: John Joseph Hewett, MD         
Sponsors and Collaborators
Synergy Health Concepts, Inc.
Principal Investigator: John Joseph Hewett, MD Study Principal Investigator

Additional Information:
Responsible Party: Synergy Health Concepts, Inc. Identifier: NCT01593358     History of Changes
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012

Keywords provided by Synergy Health Concepts, Inc.:

Additional relevant MeSH terms:
Venous Insufficiency
Neurodegenerative Diseases
Vascular Diseases
Cardiovascular Diseases
Nervous System Diseases