A Study of Stress Heart Imaging in Patients With Diabetes at Risk for Coronary Disease.

NCT ID: NCT00162344

Last Updated: 2011-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2005-12-31

Brief Summary

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The study is designed to see if stress heart imaging can be used as a screening exam in patients with diabetes and risk factors of developing of coronary artery disease and experiencing future cardiac events.

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Technetium Tc99m Sestamibi

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* History of diabetes for at least 5 years, with a least 2 risk factors (i.e. hypertension, elevated cholesterol levels, history of or current smoker, obese, family history of heart disease) \& atypical chest pain.

Exclusion Criteria

* Typical chest pain being treated with medication, unable to exercise, previous confirmed heart disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lantheus Medical Imaging

INDUSTRY

Sponsor Role lead

Responsible Party

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Lantheus Medical Imaging

Principal Investigators

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Martin Rosenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Bristol-Myers Squibb

Locations

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Local Institution

Mission Viejo, California, United States

Site Status

Local Institution

Rancho Santa Fe, California, United States

Site Status

Local Institution

San Diego, California, United States

Site Status

Local Institution

Chicago, Illinois, United States

Site Status

Local Institution

Indianapolis, Indiana, United States

Site Status

Local Institution

Detroit, Michigan, United States

Site Status

Local Institution

Minneapolis, Minnesota, United States

Site Status

Local Institution

Albany, New York, United States

Site Status

Local Institution

Roslyn, New York, United States

Site Status

Local Institution

Columbus, Ohio, United States

Site Status

Local Institution

Houston, Texas, United States

Site Status

Local Institution

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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CARDIOLITE-404

Identifier Type: -

Identifier Source: org_study_id

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