AMP as a Better Delivery System of Adenosine - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00179010

Purpose

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.

Condition	Intervention
Ischemia	Drug: Adenosine Drug: Adenosine Mono Phosphate (AMP)

Study Type:	Interventional
Study Design:	Non-Randomized, Single Blind (Subject), Active Control, Crossover Assignment, Efficacy Study
Official Title:	Use of AMP to Improve Tissue Delivery of Adenosine

Resource links provided by NLM:

Drug Information available for: Adenosine Adenosine monophosphate

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Interstitial adenosine levels [ Time Frame: Duration of ia infusion ] [ Designated as safety issue: No ]
Forearm blood flow [ Time Frame: Duration of ia infusion ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	October 2003
Estimated Study Completion Date:	January 2008
Estimated Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Intrarterial infusion of adenosine	Drug: Adenosine Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each
2: Experimental Intrarterial infusion of AMP	Drug: Adenosine Mono Phosphate (AMP) Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy volunteers
Age 18-65
Non smokers

Exclusion Criteria:

Smokers
Any chronic disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179010

Locations

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

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Italo Biaggioni, M.D.

Vanderbilt University

More Information

No publications provided

Responsible Party:	Vanderbilt University ( Italo Biaggioni )
Study ID Numbers:	030371
Study First Received:	September 13, 2005
Last Updated:	December 22, 2007
ClinicalTrials.gov Identifier:	NCT00179010 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vanderbilt University:

Adenosine
AMP
Microdialysis
Blood Flow

Study placed in the following topic categories:

Vasodilator Agents
Cardiovascular Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents

Analgesics
Ischemia
Adenosine

Additional relevant MeSH terms:

Vasodilator Agents
Physiological Effects of Drugs
Ischemia
Cardiovascular Agents
Pharmacologic Actions
Pathologic Processes
Sensory System Agents

Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Adenosine
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009