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| ID | Type | Description | Link |
|---|---|---|---|
| A-13147.1 |
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Limited numbers of patients qualified for trial
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The primary objective of this study is to understand why different people respond differently to the medication Persantine. The effects of Persantine will be evaluated by performing echocardiograms, blood tests and by measuring the flow of blood in the arteries of the heart in patients undergoing a clinically indicated percutaneous coronary intervention.
Participants will receive three doses of Persantine intravenously for the research study. Before and after receiving the Persantine doses, patients will have an echocardiogram and coronary artery blood flow will be measured. Blood tests,measure the function of the adenosine transporter. In addition variations in the gene for the adenosine transporter will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects receive dipyridamole | Other | Compare to baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dipyridamole | Drug | 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Determine if There is a Subgroup of Patients That Have an Abnormal Adenosine Transporter Expression, or Abnormal Adenosine Transporter Protein Function. | To determine if there is a subgroup of patients that have an abnormal adenosine transporter expression, or abnormal adenosine transporter protein function. All were responsive Study terminated due to difficulty enrolling | 6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow. | 6-12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Azrin, MD | University of Connecticut | Principal Investigator |
| Bruce T Liang, MD | University of Connecticut | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCONN Health Center | Farmington | Connecticut | 06030 | United States |
Study terminated due to difficulty enrolling
Study terminated due to difficulty enrolling
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects Receive Dipyridamole | There is only a single arm dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dipyridamole | Pre: Baseline Results prior to administration of Dipyridamole. Post: Results post adminsitration of Dipyridamole |
| 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 | To Determine if There is a Subgroup of Patients That Have an Abnormal Adenosine Transporter Expression, or Abnormal Adenosine Transporter Protein Function. | To determine if there is a subgroup of patients that have an abnormal adenosine transporter expression, or abnormal adenosine transporter protein function. All were responsive Study terminated due to difficulty enrolling | All patients responded. Function and Expression of the Transporter were therefore not performed. The study was terminated due to poor enrollment | Posted | 6-12 months |
|
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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 | All Subjects Receive Dipyridamole | There is only a single arm dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously |
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Trial terminated early due to poor patient enrollment. All patients responded hemodynamically. Therefore, analysis of responders vs non-responders could not be performed. Adenosine transporter was not analyzed since there was no comparator group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Azrin | UCHC | 8606793343 | azrin@uchc.edu |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004176 | Dipyridamole |
| ID | Term |
|---|---|
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
| Secondary | To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow. | The study was terminated due to poor enrollment | Posted | 6-12 months |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |