Biomagnetic Signals of Intestinal Ischemia II - Full Text View

Sponsors and Collaborators:	Vanderbilt University National Institutes of Health (NIH)
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00179036

Purpose

The lack of blood flow to the small intestine causes mesenteric ischemia. Using a Superconducting QUantum Interference Device (SQUID) which measures the magnetic field of the small intestine, we are hoping to identify abnormalities without surgical intervention.

Condition	Phase
Ischemia	Phase I

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	Biomagnetic Signals of Intestinal Ischemia II

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

To observe a difference in the magnetic activity between the normal and diseased smooth muscle of the small intestine [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Create mathematical and computer models of electrical activity of smooth muscle [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	January 2000
Estimated Study Completion Date:	June 2010

Groups/Cohorts
A Group with normal blood flow
B Group with abnormal blood flow

Detailed Description:

The electrical activity of the small intestine may contain important information that will help us diagnose gastrointestinal diseases. The major impediment to reducing mortality of mesenteric ischemia is the lack of a noninvasive diagnostic test that identifies the syndrome before extensive necrosis occurs. Mesenteric ischemia is caused by the lack of blood flow to the intestine. The Superconducting QUantum Interference Device (SQUID) measures the magnetic field of the intestinal smooth muscle. By comparing normal smooth muscle and that of patients with mesenteric ischemia, the investigators hope to identify abnormal disease states without surgery.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

primary care clinic

Criteria

Inclusion Criteria:

Normal subjects and those with diagnosed mesenteric ischemia

Exclusion Criteria:

Subjects who report a tendency toward claustrophobia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179036

Contacts

Contact: Joan Kaiser, RN

615-343-5821

joan.kaiser@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt University Medical Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Joan Kaiser, RN 615-343-5821 joan.kaiser@vanderbilt.edu
Principal Investigator: William O Richards, MD

Sponsors and Collaborators

Vanderbilt University

National Institutes of Health (NIH)

Investigators

Principal Investigator:

William O. Richards, MD

Vanderbilt University

More Information

Responsible Party:	Vanderbilt University ( Dr. William O. Richards )
Study ID Numbers:	060426, NIH RO1 DK 58197-05
Study First Received:	September 13, 2005
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00179036
Health Authority:	United States: Federal Government

Keywords provided by Vanderbilt University:

Blood supply
Mesentery

Study placed in the following topic categories:

Ischemia

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009