AMP as a Better Delivery System of Adenosine - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

December 22, 2007

Start Date ^ICMJE

October 2003

Estimated Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Interstitial adenosine levels
Forearm blood flow
Heart rate
Blood pressure

Change History

Complete list of historical versions of study NCT00179010 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Symptoms

Descriptive Information

Brief Title ^ICMJE

AMP as a Better Delivery System of Adenosine

Official Title ^ICMJE

Use of AMP to Improve Tissue Delivery of Adenosine

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Non-Randomized, Single Blind (Subject), Active Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Ischemia

Intervention ^ICMJE

Drug: Adenosine
Drug: Adenosine Mono Phosphate (AMP)

Study Arms / Comparison Groups

Experimental: Intrarterial infusion of adenosine
Experimental: Intrarterial infusion of AMP

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2008

Estimated Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy volunteers
Age 18-65
Non smokers

Exclusion Criteria:

Smokers
Any chronic disease

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00179010

Responsible Party

Italo Biaggioni, Vanderbilt University

Study ID Numbers ^ICMJE

030371

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Italo Biaggioni, M.D.

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP