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AMP as a Better Delivery System of Adenosine

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ClinicalTrials.gov Identifier: NCT00179010
Recruitment Status : Terminated (Study was terminated because funding could not be secured)
First Posted : September 15, 2005
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Basic Science
Condition Ischemia
Interventions Drug: Adenosine
Drug: Adenosine Mono Phosphate (AMP)
Enrollment 13
Recruitment Details Subjects were recruited through mass e-mails and flyers posted in campus
Pre-assignment Details Subjects were randomly assigned to each treatment arm, after being screened for any medical problem that would be considered a contraindication for the study according to the physician performing the initial evaluation. Once subjects completed one arm, they were crossed to the other arm and studied at lest one month after.
Arm/Group Title Adenosine First Then AMP Adenosine Mono Phosphate (AMP) First Then Adenosine
Hide Arm/Group Description

Intrarterial infusion of adenosine first

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

Subjects in this group were assigned to received intrarterial infusions of adenosine and then crossed to the other arm (AMP) after at least 1 month.

Intrarterial infusion of AMP first

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

Subjects intros group were assigned to received intrarterial infusions of AMP and then crossed to the other arm (adenosine), at least 1 month after.

Period Title: Overall Study
Started 6 7
Completed 5 5
Not Completed 1 2
Reason Not Completed
Muscle probe defective             1             1
Failure to place arterial line             0             1
Arm/Group Title Adenosine Mono Phosphate (AMP) First Adenosine First Total
Hide Arm/Group Description

Intrarterial infusion of AMP

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

Intrarterial infusion of adenosine

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

Total of all reporting groups
Overall Number of Baseline Participants 7 6 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
6
 100.0%
13
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 6 participants 13 participants
37  (10) 37  (10) 37  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
Female
3
  42.9%
3
  50.0%
6
  46.2%
Male
4
  57.1%
3
  50.0%
7
  53.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 7 participants 6 participants 13 participants
7
 100.0%
6
 100.0%
13
 100.0%
1.Primary Outcome
Title Interstitial Adenosine Levels
Hide Description [Not Specified]
Time Frame Microdyalysis samples for adenosine, were collected for 15 minutes at each stage of the study (baseline and each dose of adenosine or AMP)
Hide Outcome Measure Data
Hide Analysis Population Description
13 subjects received both treatments. 3 subject did not complete the study and were excluded. We are reporting data in only 10 subjects that have collected samples.
Arm/Group Title Adenosine Adenosine Mono Phosphate (AMP)
Hide Arm/Group Description:

Intrarterial infusion of adenosine

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

Intra-arterial infusion of AMP
Overall Number of Participants Analyzed 10 10
Mean (Standard Error)
Unit of Measure: nM
Third dose 93.2  (15.7) 91.7  (13.8)
Second Dose 87.5  (12.7) 91.1  (18.9)
First Dose 89.8  (18.6) 86.2  (13.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adenosine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.854
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Other Pre-specified Outcome
Title Forearm Blood Flow
Hide Description [Not Specified]
Time Frame End of each stage (minute 15) of the study (baseline and each dose of adenosine or AMP ia infusions)
Hide Outcome Measure Data
Hide Analysis Population Description
This was an exploratory Outcome and was abandoned.
Arm/Group Title Adenosine Adenosine Mono Phosphate (AMP)
Hide Arm/Group Description:

Intrarterial infusion of adenosine

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

Intrarterial infusion of AMP

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adenosine Adenosine Mono Phosphate (AMP)
Hide Arm/Group Description

Intrarterial infusion of adenosine

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

Intrarterial infusion of AMP

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

All-Cause Mortality
Adenosine Adenosine Mono Phosphate (AMP)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adenosine Adenosine Mono Phosphate (AMP)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adenosine Adenosine Mono Phosphate (AMP)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Italo Biaggioni, MD., Professor of Medicine and Pharmacology
Organization: Vanderbilt University
Phone: (615) 936-3420
EMail: italo.biaggioni@vanderbilt.edu
Layout table for additonal information
Responsible Party: Italo Biaggioni, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00179010     History of Changes
Other Study ID Numbers: 030371
First Submitted: September 13, 2005
First Posted: September 15, 2005
Results First Submitted: July 13, 2015
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019