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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:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179010
First received: September 13, 2005
Last updated: March 30, 2011
Last verified: March 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Use of AMP to Improve Tissue Delivery of Adenosine

Resource links provided by NLM:

Drug Information available for: Adenosine
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Interstitial adenosine levels [ Time Frame: Duration of ia infusion ] [ Designated as safety issue: No ]
  • Forearm blood flow [ Time Frame: Duration of ia infusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: October 2003
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Age 18-65
  • Non smokers

Exclusion Criteria:

  • Smokers
  • Any chronic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Italo Biaggioni, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00179010     History of Changes
Other Study ID Numbers: 030371
Study First Received: September 13, 2005
Last Updated: March 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 16, 2013