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Study was terminated because funding could not be secured
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adenosine then Adenosine Mono Phosphate (AMP) | Experimental | Intrarterial infusion of adenosine then same subject switch to AMP one month apart. |
|
| Adenosine Mono Phosphate (AMP) then adenosine | Experimental | Intrarterial infusion of AMP then same subject switch to Adenosine one month apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adenosine | Drug | Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| Forearm Blood Flow | End of each stage (minute 15) of the study (baseline and each dose of adenosine or AMP ia infusions) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Italo Biaggioni, M.D. | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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.
Subjects were recruited through mass e-mails and flyers posted in campus
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| ID | Title | Description |
|---|---|---|
| FG000 | Adenosine First Then AMP | 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. |
| FG001 | Adenosine Mono Phosphate (AMP) First Then Adenosine | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adenosine Mono Phosphate (AMP) First | 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) |
| BG001 | Adenosine First |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Interstitial Adenosine Levels | 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. | Posted | Mean | Standard Error | nM | Microdyalysis samples for adenosine, were collected for 15 minutes at each stage of the study (baseline and each dose of adenosine or AMP) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adenosine | Intrarterial infusion of adenosine Adenosine: Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Italo Biaggioni, MD., Professor of Medicine and Pharmacology | Vanderbilt University | (615) 936-3420 | italo.biaggioni@vanderbilt.edu |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000241 | Adenosine |
| C110027 | beta-apocarotenoid-14',13'-dioxygenase |
| D000249 | Adenosine Monophosphate |
| ID | Term |
|---|---|
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Adenosine Mono Phosphate (AMP) | Drug | 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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Other Pre-specified | Forearm Blood Flow | This was an exploratory Outcome and was abandoned. | Posted | End of each stage (minute 15) of the study (baseline and each dose of adenosine or AMP ia infusions) |
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Adenosine Mono Phosphate (AMP) | 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) | 0 | 13 | 0 | 13 |
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| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |