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AMP as a Better Delivery System of Adenosine

This study has suspended participant recruitment.
(In process of renewing IND for AMP)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00179010
First Posted: September 15, 2005
Last Update Posted: October 12, 2017
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):
Italo Biaggioni, Vanderbilt University
  Purpose
Adenosine and AMP are substances normally present in the body. Adenosine is also given for the treatment of some heart rhythm problems and may be used to reduce heart damage during heart attacks. The problem in using adenosine is that it is taken up by cells and, therefore, very little of the adenosine we give by vein or in the artery actually reaches the tissue. We propose to use AMP as a way to improve delivery of adenosine. AMP is inactive by itself, but is converted to adenosine in tissue. We hope that by giving AMP we will increase levels of adenosine in tissue. To see if this is true, we will give either adenosine or AMP into the forearm artery while we measure how much adenosine reaches the forearm tissue.

Condition Intervention
Ischemia Drug: Adenosine Drug: Adenosine Mono Phosphate (AMP)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Use of AMP to Improve Tissue Delivery of Adenosine

Resource links provided by NLM:


Further study details as provided by Italo Biaggioni, Vanderbilt University:

Primary Outcome Measures:
  • Interstitial adenosine levels [ Time Frame: Duration of ia infusion ]
  • Forearm blood flow [ Time Frame: Duration of ia infusion ]

Estimated Enrollment: 64
Study Start Date: October 2003
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intrarterial infusion of adenosine
Drug: Adenosine
Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each
Experimental: 2
Intrarterial infusion of AMP
Drug: Adenosine Mono Phosphate (AMP)
Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Age 18-65
  • Non smokers

Exclusion Criteria:

  • Smokers
  • Any chronic disease
  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): NCT00179010


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Italo Biaggioni, M.D. Vanderbilt University
  More Information

Responsible Party: Italo Biaggioni, Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00179010     History of Changes
Other Study ID Numbers: 030371
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: October 12, 2017
Last Verified: February 2015

Keywords provided by Italo Biaggioni, Vanderbilt University:
Adenosine
AMP
Microdialysis
Blood Flow

Additional relevant MeSH terms:
Ischemia
Pathologic Processes
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action