NCT00380198

Brief Summary

The purpose of this clinical research study is to compare Apadenoson and adenosine to treadmill exercise stress SPECT MPI

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for phase_3 coronary-artery-disease

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_3 coronary-artery-disease

Geographic Reach
1 country

42 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

September 21, 2006

Last Update Submit

January 31, 2017

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Agreement between MPI Summed Stress Scores for extent and severity of disease

Secondary Outcomes (1)

  • Comparison of imaging data to 6 month event data or angiography

Interventions

ApadenosonDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically appropriate for exercise stress testing

You may not qualify if:

  • Contraindication to adenosine stress or inability to perform treadmill exercise test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (42)

Local Institution

Huntsville, Alabama, 35801, United States

Location

Local Institution

Santa Rosa, California, 95405, United States

Location

Local Institution

Bridgeport, Connecticut, 06606, United States

Location

Local Institution

Guilford, Connecticut, 06437, United States

Location

Local Institution

Newark, Delaware, 19713, United States

Location

Local Institution

Fort Lauderdale, Florida, 33308, United States

Location

Local Institution

Gainsville, Florida, 32605, United States

Location

Local Institution

Jacksonville, Florida, 32207, United States

Location

Local Institution

Jacksonville, Florida, 32258, United States

Location

Local Institution

Jacksonville Beach, Florida, 32250, United States

Location

Local Institution

Jupiter, Florida, 33458, United States

Location

Local Institution

Miami, Florida, 33173, United States

Location

Local Institution

Stuart, Florida, 34996, United States

Location

Local Institution

Tamarac, Florida, 33321, United States

Location

Local Institution

Honolulu, Hawaii, 96813, United States

Location

Local Institution

Aurora, Illinois, 60504, United States

Location

Local Institution

Bannockburn, Illinois, 60015, United States

Location

Local Institution

LaGrange, Illinois, 60525, United States

Location

Local Institution

Lombard, Illinois, 60148, United States

Location

Local Institution

Winfield, Illinois, 60190, United States

Location

Local Institution

Indianapolis, Indiana, 46290, United States

Location

Local Institution

Overland Park, Kansas, 66209, United States

Location

Local Institution

Louisville, Kentucky, 40205, United States

Location

Local Institution

Baton Rouge, Louisiana, 70808, United States

Location

Local Institution

Auburn, Maine, 04210, United States

Location

Local Institution

Westminster, Maryland, 21157, United States

Location

Local Institution

Saint Louis Park, Minnesota, 54416, United States

Location

Local Institution

Tupelo, Mississippi, 38801, United States

Location

Local Institution

Kansas City, Missouri, 64132, United States

Location

Local Institution

Albany, New York, 12205, United States

Location

Local Institution

West Islip, New York, 11795, United States

Location

Local Institution

Cincinnati, Ohio, 45219, United States

Location

Local Institution

Lorain, Ohio, 44053, United States

Location

Local Institution

Sandusky, Ohio, 44870, United States

Location

Local Institution

Westlake, Ohio, 44145, United States

Location

Local Institution

Wyomissing, Pennsylvania, 19610, United States

Location

Local Institution

Simpsonville, South Carolina, 29681, United States

Location

Local Institution

Chattanooga, Tennessee, 37404, United States

Location

Local Institution

Johnson City, Tennessee, 37604, United States

Location

Local Institution

Houston, Texas, 77090, United States

Location

Local Institution

Richmond, Virginia, 23229, United States

Location

Local Institution

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Robert Mittleman, MD

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 21, 2006

First Posted

September 25, 2006

Study Start

July 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

US(42)