NCT00760708

Brief Summary

Persantine is a drug that is routinely used to determine blood flow to the heart in the diagnosis of coronary heart disease. Persantine causes an increase in the adenosine level in the blood. Adenosine is a naturally occurring substance in the body that can increase blood flow. Adenosine is normally removed from the bloodstream by an adenosine transporter, which is a protein that takes up adenosine from the blood into cells. The increase in adenosine levels in the blood is variable, and the cause for this variability is unknown. A mutation for this transporter gene may contribute to this variability, and may alter its function. Thus, the purpose of this study is to determine the relationship between the mutation and the transporter function.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

6.3 years

First QC Date

September 24, 2008

Last Update Submit

May 10, 2019

Conditions

Keywords

nucleosidesneurotransmittermyocardial ischemiaAdenosine

Outcome Measures

Primary Outcomes (1)

  • To determine functional significance and association of these polymorphisms with the ability of persantine to inhibit uridine (uridine uses the same transporter) uptake and platelet aggregation.

    24 hours

Secondary Outcomes (1)

  • Investigators will study the association of these polymorphisms with any clinical characteristics such as the incidence of MI, acute coronary syndrome, coronary bypass or stenting procedures. These clinical outcomes are considered secondary endpoints.

    2 years

Study Arms (1)

undergoing persantine stress test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects undergoing a Persantine nuclear stress test for medically-indicated reasons. There are no control subjects.

You may qualify if:

  • Subjects with or without coronary artery disease undergoing a Persantine nuclear stress test

You may not qualify if:

  • Oral persantine use within 24 hours
  • Second or third degree AV block, or sick sinus syndrome without a functioning pacemaker
  • Active asthma or bronchospasm
  • Those with end-stage liver disease such as cirrhosis or active hepatitis such as \> 5 fold liver enzyme elevation will not be included
  • Anemia (Hct \< 30)
  • Myocardial infarction within 30 days
  • Severe left ventricular dysfunction (EF \< 30%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06032, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

IschemiaCoronary DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Bruce T Liang, MD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Director Pat and Jim Calhoun Cardiovascular Center

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 26, 2008

Study Start

September 1, 2005

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 14, 2019

Record last verified: 2019-05

Locations