Persantine: Variation in Response Trial

Coronary Artery Disease Clinical Trial

Official title:

Persantine: Variation in Response Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00763009
• Other study ID #: 02-202-1
• Secondary ID: A-13147.1
• Status: Terminated
• Phase: Phase 4
• First received: September 24, 2008
• Last updated: March 14, 2018
• Start date: September 2002
• Est. completion date: July 2009

Study information

• Verified date: March 2018
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• dipyridamole
0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously

Locations

Country	Name	City	State
United States	UCONN Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	6-12 months
Secondary	To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow.		6-12 months