Biomarkers of Ischemia: Xanthine, Hypoxanthine and Inosine Levels During Carotid Stenting Procedures

July 27, 2018 updated by: Virginia Commonwealth University
The purpose of the study is to determine if a new blood test can help the doctor determine if there is brain injury or ischemia. Ischemia occurs when not enough oxygen gets to the brain. In this study the investigators are analyzing your blood for a new test that might help doctors decide if symptoms are from a neurologic problem.

Study Overview

Status

Completed

Conditions

Detailed Description

We will compare a new blood test with routine tests that the doctor will order as part of your normal care. This study will measure new biomarkers (biomarker is a specific distinguishing feature used to measure or indicate the effects or progress of a disease or condition) of neurologic stress called xanthine, hypoxanthine, and inosine. Blood will be drawn as a part of the study to measure these biomarker levels in your blood. This blood will be analyzed i the laboratory at Virginia Commonwealth University and possibly at a future date at another institution. No names will be associated with the blood sample

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for Carotid Stenting Procedure at Virginia Commonwealth University

Description

Inclusion Criteria:

  • Men and Women over age of 18 non
  • Women who are not pregnant
  • Subject who are not prisoners
  • Subjects presenting to the operation room for a Carotid artery stenting procedure
  • Hemoglobin greater than or equal to 11mg/dl
  • Subjects who speak english
  • Subjects 18 years of age or older

Exclusion Criteria:

  • Hemoglobin less than 11mg/dl
  • Women who are pregnant
  • Children under age of 18
  • Prisoners
  • Non English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Biomarkers, Carotid Stenting, Blood sample
Subjects requiring Carotid Stenting Procedure at Virginia Commonwealth University/Medical College of Virginia Health Systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers of Ischemia: Levels of Xanthine, Hypoxanthine and Inosine during Carotid Stenting Procedures
Time Frame: analysis will occur after all samples collected
To compare a new blood test with can help the doctor determine if there is a brain injury or ischemia, The study will measure new biomarkers of neurologic stress called xanthine, hypoxanthine and inosine. Blood will be drawn as a part of the study to measure these biomarker levels in the blood. The blood will be analyzed in the laboratory at VCU.
analysis will occur after all samples collected

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Lynne Gehr, MD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

October 9, 2013

Study Completion (ACTUAL)

October 9, 2013

Study Registration Dates

First Submitted

July 10, 2012

First Submitted That Met QC Criteria

July 11, 2012

First Posted (ESTIMATE)

July 12, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM12941

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Identify the Presence of a Marker of Ischemia/Hypoperfusion of the Brain Via Peripheral Blood

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe