Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty

NCT ID: NCT00162357

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

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-12-31

Brief Summary

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The purpose of this clinical research study is determine if patients with diabetes that have undergone previous opening of a heart blockage may have a blockage that is not causing any symptoms that may be detected by imaging with Cardiolite.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Coronary Restenosis

Study Design

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Allocation Method

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

* Type II Diabetes on medication \& angioplasty within the past 6 months.

Exclusion Criteria

* Myocardial infarction or repeat angioplasty with the past 5 months.
* Unable to perform exercise or pharmacologic stress test.
Minimum Eligible Age

21 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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Qi Zhu, MD

Role: STUDY_DIRECTOR

Lantheus Medical Imaging

Locations

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Local Institution

Hartford, Connecticut, United States

Site Status

Local Institution

Waterbury, Connecticut, United States

Site Status

Local Institution

Grand Rapids, Michigan, United States

Site Status

Local Institution

Roslyn, New York, United States

Site Status

Local Institution

Burlington, Vermont, United States

Site Status

Local Institution

Roanoke, Virginia, United States

Site Status

Local Institution

Wausau, Wisconsin, United States

Site Status

Local Institution

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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CARDIOLITE-406

Identifier Type: -

Identifier Source: org_study_id

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