AMP as a Better Delivery System of Adenosine

May 3, 2019 updated by: Italo Biaggioni, Vanderbilt University Medical Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

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
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers
  • Age 18-65
  • Non smokers

Exclusion Criteria:

  • Smokers
  • Any chronic disease

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

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Adenosine then Adenosine Mono Phosphate (AMP)
Intrarterial infusion of adenosine then same subject switch to AMP one month apart.
Drug: Adenosine
Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each
Other Names:
  • Ado
Drug: Adenosine Mono Phosphate (AMP)
Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)
Other Names:
  • AMP
EXPERIMENTAL: Adenosine Mono Phosphate (AMP) then adenosine
Intrarterial infusion of AMP then same subject switch to Adenosine one month apart.
Drug: Adenosine
Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each
Other Names:
  • Ado
Drug: Adenosine Mono Phosphate (AMP)
Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)
Other Names:
  • AMP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Microdyalysis samples for adenosine, were collected for 15 minutes at each stage of the study (baseline and each dose of adenosine or AMP)

Other Outcome Measures

Outcome Measure
Time Frame
Forearm Blood Flow
Time Frame: End of each stage (minute 15) of the study (baseline and each dose of adenosine or AMP ia infusions)
End of each stage (minute 15) of the study (baseline and each dose of adenosine or AMP ia infusions)

Collaborators and Investigators

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

Sponsor

Vanderbilt University Medical Center

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

October 1, 2003

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 15, 2005

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030371

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

Subscribe