Coronary Artery Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGdipyridamole
0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously
Sponsors
United States Department of Defense
UConn Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \> 21 years old * Patient undergoing cardiac catheterization with planned PTCA or with a significant coronary lesion of either the LAD or Circumflex
Exclusion criteria
* Theophylline or oral Persantine use in 24hrs * Second or third degree AV block, or sick sinus syndrome without a functioning pacemaker * Active asthma or bronchospasm * Patients with severe hepatic insufficiency * Patients experiencing an acute transmural infarction at the time of the index visit * Conditions that are known to affect resistive vessel function or myocardial flow
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine if There is a Subgroup of Patients That Have an Abnormal Adenosine Transporter Expression, or Abnormal Adenosine Transporter Protein Function. | 6-12 months | 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 |
Secondary
| Measure | Time frame |
|---|---|
| To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow. | 6-12 months |
Countries
United States
Participant flow
Recruitment details
Study terminated due to difficulty enrolling
Pre-assignment details
Study terminated due to difficulty enrolling
Participants by arm
| Arm | Count |
|---|---|
| Dipyridamole Pre: Baseline Results prior to administration of Dipyridamole. Post: Results post adminsitration of Dipyridamole | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Coronary Anatomy unsuitable | 1 |
Baseline characteristics
| Characteristic | Dipyridamole |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
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
Time frame: 6-12 months
Population: All patients responded. Function and Expression of the Transporter were therefore not performed.~The study was terminated due to poor enrollment
Secondary
To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow.
Time frame: 6-12 months
Population: The study was terminated due to poor enrollment