AMP as a Better Delivery System of Adenosine

Phase 1

Terminated

• Conditions: Ischemia
• Interventions: Drug: Adenosine; Drug: Adenosine Mono Phosphate (AMP)

• Registration Number: NCT00179010
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Results First Submitted: 2015-07-13
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-03
• Last Update Submitted: 2019-05-03
• Results First Posted: 2019-05-07
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Healthy volunteers
• Age 18-65
• Non smokers

Exclusion Criteria

• Smokers
• Any chronic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Adenosine then Adenosine Mono Phosphate (AMP)	Adenosine Mono Phosphate (AMP)	Intrarterial infusion of adenosine then same subject switch to AMP one month apart.
Adenosine Mono Phosphate (AMP) then adenosine	Adenosine Mono Phosphate (AMP)	Intrarterial infusion of AMP then same subject switch to Adenosine one month apart.
Adenosine then Adenosine Mono Phosphate (AMP)	Adenosine	Intrarterial infusion of adenosine then same subject switch to AMP one month apart.
Adenosine Mono Phosphate (AMP) then adenosine	Adenosine	Intrarterial infusion of AMP then same subject switch to Adenosine one month apart.

Primary Outcome Measures

Name	Time	Method
Interstitial Adenosine Levels	Microdyalysis samples for adenosine, were collected for 15 minutes at each stage of the study (baseline and each dose of adenosine or AMP)

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States