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Venous Obstruction in Neurodegenerative Disorders Research Registry

This study is currently recruiting participants.
Verified May 2012 by Synergy Health Concepts, Inc.
Sponsor:
Information provided by (Responsible Party):
Synergy Health Concepts, Inc.
ClinicalTrials.gov Identifier:
NCT01593358
First received: May 5, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
CCSVI Alliance Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Synergy Health Concepts, Inc.
ClinicalTrials.gov Identifier: NCT01593358     History of Changes
Other Study ID Numbers: RESEARCH_REGISTRY
Study First Received: May 5, 2012
Last Updated: May 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Synergy Health Concepts, Inc.:
CCSVI

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

ClinicalTrials.gov processed this record on May 22, 2013