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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

September 13, 2005
March 30, 2011
October 2003
January 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Interstitial adenosine levels
  • Forearm blood flow
  • Heart rate
  • Blood pressure
Complete list of historical versions of study NCT00179010 on ClinicalTrials.gov Archive Site
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Symptoms
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AMP as a Better Delivery System of Adenosine
Use of AMP to Improve Tissue Delivery of Adenosine

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.
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Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Ischemia
  • Drug: Adenosine
    Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each
  • Drug: Adenosine Mono Phosphate (AMP)
    Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)
  • Experimental: 1
    Intrarterial infusion of adenosine
    Intervention: Drug: Adenosine
  • Experimental: 2
    Intrarterial infusion of AMP
    Intervention: Drug: Adenosine Mono Phosphate (AMP)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
64
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers
  • Age 18-65
  • Non smokers

Exclusion Criteria:

  • Smokers
  • Any chronic disease
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00179010
030371
No
Italo Biaggioni, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Italo Biaggioni, M.D. Vanderbilt University
Vanderbilt University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP