AMP as a Better Delivery System of Adenosine

NCT ID: NCT00179010

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2017-01-31

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.

Conditions

Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Adenosine then Adenosine Mono Phosphate (AMP)

Intrarterial infusion of adenosine then same subject switch to AMP one month apart.

Group Type: EXPERIMENTAL

Adenosine

Intervention Type: DRUG

Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each

Adenosine Mono Phosphate (AMP)

Intervention Type: DRUG

Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)

Adenosine Mono Phosphate (AMP) then adenosine

Intrarterial infusion of AMP then same subject switch to Adenosine one month apart.

Group Type: EXPERIMENTAL

Adenosine

Intervention Type: DRUG

Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each

Adenosine Mono Phosphate (AMP)

Intervention Type: DRUG

Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)

Interventions

Adenosine

Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each

Intervention Type: DRUG

Adenosine Mono Phosphate (AMP)

Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)

Intervention Type: DRUG

Other Intervention Names

Ado; AMP

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers
• Age 18-65
• Non smokers

Exclusion Criteria

• Smokers
• Any chronic disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Italo Biaggioni

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Italo Biaggioni, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

030371

Identifier Type: -

Identifier Source: org_study_id