Back to resultsAMP as a Better Delivery System of Adenosine
Primary Purpose
Ischemia
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adenosine
Adenosine Mono Phosphate (AMP)
Sponsored by
About this trial
This is an interventional basic science trial for Ischemia focused on measuring Adenosine, AMP, Microdialysis, Blood Flow
Eligibility Criteria
Inclusion Criteria: Healthy volunteers Age 18-65 Non smokers Exclusion Criteria: Smokers Any chronic disease
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Adenosine then Adenosine Mono Phosphate (AMP)
Adenosine Mono Phosphate (AMP) then adenosine
Arm Description
Intrarterial infusion of adenosine then same subject switch to AMP one month apart.
Intrarterial infusion of AMP then same subject switch to Adenosine one month apart.
Outcomes
Primary Outcome Measures
Interstitial Adenosine Levels
Secondary Outcome Measures
Full Information
NCT ID
NCT00179010
First Posted
September 13, 2005
Last Updated
May 3, 2019
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00179010
Brief Title
AMP as a Better Delivery System of Adenosine
Official Title
Use of AMP to Improve Tissue Delivery of Adenosine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated because funding could not be secured
Study Start Date
October 2003 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia
Keywords
Adenosine, AMP, Microdialysis, Blood Flow
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adenosine then Adenosine Mono Phosphate (AMP)
Arm Type
Experimental
Arm Description
Intrarterial infusion of adenosine then same subject switch to AMP one month apart.
Arm Title
Adenosine Mono Phosphate (AMP) then adenosine
Arm Type
Experimental
Arm Description
Intrarterial infusion of AMP then same subject switch to Adenosine one month apart.
Intervention Type
Drug
Intervention Name(s)
Adenosine
Other Intervention Name(s)
Ado
Intervention Description
Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each
Intervention Type
Drug
Intervention Name(s)
Adenosine Mono Phosphate (AMP)
Other Intervention Name(s)
AMP
Intervention Description
Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)
Primary Outcome Measure Information:
Title
Interstitial Adenosine Levels
Time Frame
Microdyalysis samples for adenosine, were collected for 15 minutes at each stage of the study (baseline and each dose of adenosine or AMP)
Other Pre-specified Outcome Measures:
Title
Forearm Blood Flow
Time Frame
End of each stage (minute 15) of the study (baseline and each dose of adenosine or AMP ia infusions)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers
Age 18-65
Non smokers
Exclusion Criteria:
Smokers
Any chronic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Italo Biaggioni, M.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
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AMP as a Better Delivery System of Adenosine
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