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Venous Obstruction in Neurodegenerative Disorders Research Registry

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Synergy Health Concepts, Inc..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01593358
First Posted: May 8, 2012
Last Update Posted: May 8, 2012
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.
Information provided by (Responsible Party):
Synergy Health Concepts, Inc.
  Purpose
To establish if there are venous obstructions in patients with neurodegenerative disorders

Condition
Chronic Cerebral Spinal Venous Insufficiency

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Venous Obstruction in Neurodegenerative Disorders Research Registry

Resource links provided by NLM:


Further study details as provided by Synergy Health Concepts, Inc.:

Estimated Enrollment: 2000
Study Start Date: August 2011
Estimated Study Completion Date: January 2014
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.
  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:   18 Years to 90 Years   (Adult, Senior)
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.
Criteria

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
  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): NCT01593358


Contacts
Contact: Frances DeBarge-Igoe, RN (949) 221-0129 uscangionurse@aol.com

Locations
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.
Investigators
Principal Investigator: John Joseph Hewett, MD Study Principal Investigator
  More Information

Additional Information:
Responsible Party: Synergy Health Concepts, Inc.
ClinicalTrials.gov Identifier: NCT01593358     History of Changes
Other Study ID Numbers: RESEARCH_REGISTRY
First Submitted: May 5, 2012
First Posted: May 8, 2012
Last Update Posted: May 8, 2012
Last Verified: May 2012

Keywords provided by Synergy Health Concepts, Inc.:
CCSVI

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