NCT00162071

Brief Summary

The primary purpose of this study is to determine the optimal time for myocardial perfusion imaging with Technetium Tc99m Sestamibi following the administration of BMS068645. The safety of BMS068645 will also be studied.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

September 9, 2005

Last Update Submit

January 31, 2017

Conditions

Cardiovascular DiseaseIschemic Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Measurements of Technetium Tc99m Sestamibi activity will be obtained from various regions of the body at the end of the study to determine optimal imaging times.

Secondary Outcomes (1)

  • A comparison of adverse events will be conducted at the end of the study to assess safety.

Interventions

apadenosonDRUG

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Have known or suspected heart disease
  • Have undergone a clinically indicated SPECT MPI study with adenosine in the last 24 hours to 14 days.
  • Weigh between 88 and 250 lbs.

You may not qualify if:

  • Allergic reaction to Technetium Tc99m Sestamibi or any of its components
  • History of asthma or lung disease
  • Ingestion of caffeinated substances within 12 hours prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesVascular Diseases

Study Officials

  • E Gordon DePuey, MD

    St. Luke's-Roosevelt Hospital Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

July 1, 2005

Primary Completion

March 1, 2006

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

US(1)