NCT00179010

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

May 7, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

13.3 years

First QC Date

September 13, 2005

Results QC Date

July 13, 2015

Last Update Submit

May 3, 2019

Conditions

Ischemia

Keywords

AdenosineAMPMicrodialysisBlood Flow

Outcome Measures

Primary Outcomes (1)

  • 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)

Other Outcomes (1)

  • Forearm Blood Flow

    End of each stage (minute 15) of the study (baseline and each dose of adenosine or AMP ia infusions)

Study Arms (2)

Adenosine then Adenosine Mono Phosphate (AMP)

EXPERIMENTAL

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

Drug: AdenosineDrug: Adenosine Mono Phosphate (AMP)

Adenosine Mono Phosphate (AMP) then adenosine

EXPERIMENTAL

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

Drug: AdenosineDrug: Adenosine Mono Phosphate (AMP)

Interventions

AdenosineDRUG

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

Also known as: Ado
Adenosine Mono Phosphate (AMP) then adenosineAdenosine then Adenosine Mono Phosphate (AMP)
Adenosine Mono Phosphate (AMP)DRUG

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

Also known as: AMP
Adenosine Mono Phosphate (AMP) then adenosineAdenosine then Adenosine Mono Phosphate (AMP)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers
  • Age 18-65
  • Non smokers

You may not qualify if:

  • Smokers
  • Any chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Ischemia

Interventions

Adenosinebeta-apocarotenoid-14',13'-dioxygenaseAdenosine Monophosphate

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesAdenine NucleotidesPurine NucleotidesNucleotidesRibonucleotides

Results Point of Contact

Title
Italo Biaggioni, MD., Professor of Medicine and Pharmacology
Organization
Vanderbilt University
italo.biaggioni@vanderbilt.edu
(615) 936-3420

Study Officials

  • Italo Biaggioni, M.D.

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

October 1, 2003

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

May 7, 2019

Results First Posted

May 7, 2019

Record last verified: 2019-05

Locations

US(1)