Back to resultsPersantine: Variation in Response Trial
Primary Purpose
Coronary Artery Disease
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
dipyridamole
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- UCONN Health Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All subjects receive dipyridamole
Arm Description
Compare to baseline
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow.
Full Information
NCT ID
NCT00763009
First Posted
September 24, 2008
Last Updated
March 14, 2018
Sponsor
UConn Health
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT00763009
Brief Title
Persantine: Variation in Response Trial
Official Title
Persantine: Variation in Response Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Limited numbers of patients qualified for trial
Study Start Date
September 2002 (Actual)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All subjects receive dipyridamole
Arm Type
Other
Arm Description
Compare to baseline
Intervention Type
Drug
Intervention Name(s)
dipyridamole
Other Intervention Name(s)
Persantine
Intervention Description
0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously
Primary Outcome Measure Information:
Title
To Determine if There is a Subgroup of Patients That Have an Abnormal Adenosine Transporter Expression, or Abnormal Adenosine Transporter Protein Function.
Description
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
Secondary Outcome Measure Information:
Title
To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow.
Time Frame
6-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Azrin, MD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruce T Liang, MD
Organizational Affiliation
University of Connecticut
Official's Role
Study Chair
Facility Information:
Facility Name
UCONN Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Persantine: Variation in Response Trial
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