AMP as a Better Delivery System of Adenosine

Ischemia Clinical Trial

Official title:

Use of AMP to Improve Tissue Delivery of Adenosine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00179010
• Other study ID #: 030371
• Status: Terminated
• Phase: Phase 1
• Start date: October 2003
• Est. completion date: January 2017

Study information

• Verified date: May 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

• Age 18-65

• Non smokers

Exclusion Criteria:

• Smokers

• Any chronic disease

Related Conditions & MeSH terms

• Ischemia

Intervention

Drug:
• Adenosine
Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each
• Adenosine Mono Phosphate (AMP)
Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Forearm Blood Flow		End of each stage (minute 15) of the study (baseline and each dose of adenosine or AMP ia infusions)
Primary	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)