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Comparison of Diagnostic Rest/Stress SPECT Results for Patients With Myocardial Ischemia and Infarction Using Myoview in Both Single and Dual Isotope Acquisition Approaches

NCT ID: NCT00381316

Last Updated: 2007-12-05

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

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2006-12-31

Brief Summary

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The study is designed to determine whether a dual isotope protocol is equivalent to a single isotope in the diagnosis of myocardial ischemia and infarction using MYOVIEW SPECT imaging.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Thallous Chloride T1-201

Group Type ACTIVE_COMPARATOR

Thallous Chloride T1-201

Intervention Type DRUG

Myoview SPECT Imaging

2

Technetium Tc99m Tetrofosmin injections

Group Type ACTIVE_COMPARATOR

Technetium Tc99m Tetrofosmin injections

Intervention Type DRUG

Single Isotope: be 555 to 888 MBq (15 to 24 mCi) MYOVIEW at Rest/i.v./bolus.

Interventions

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Technetium Tc99m Tetrofosmin injections

Single Isotope: be 555 to 888 MBq (15 to 24 mCi) MYOVIEW at Rest/i.v./bolus.

Intervention Type DRUG

Thallous Chloride T1-201

Myoview SPECT Imaging

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. The subject is 18 years old or older.
2. Male subjects or non-lactating female subjects, who are either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or for women of childbearing potential, the results of a serum or urine human chorionic gonadotropin pregnancy test, performed at screening within 24 hours before dosing (with the result known before investigational medicinal product administration) must be negative.
3. The subject is able and willing to comply with study procedures (i.e., 1 SPECT imaging at Stress, 2 SPECT imagings at Rest) and signed and dated informed consent is obtained.
4. The subject is suspected of or known of having CAD based on the subject's clinical signs, symptoms, or examinations .
5. The subject is referred for Rest/Stress (exercise or pharmacological) MPS-SPECT for known or suspected CAD (as clinically required).

Exclusion Criteria

1. The subject was previously included in this study.
2. The subject received an IMP within 30 days before or is scheduled to receive one during or in the next 30 days after IMP administration.
3. The subject has known allergies to any product used in this study or its constituents, including subjects who are not able to exercise and have contraindications to Adenosine (e.g., Asthmatics).
4. The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month.
5. The subject has no contraindications to any of the study procedures (e.g. physical exercise) or the involved drugs (Myoview, Thallium-201, Adenosine or Dipyridamole) such as e.g. 2nd or 3rd degree AV-block, SS syndrome, bradycardia, bronchoconstrictive or bronchospastic lung disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role lead

Principal Investigators

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Andre Mueller-York

Role: STUDY_DIRECTOR

GE Healthcare

Locations

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GE Healthcare

Princeton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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143-002

Identifier Type: -

Identifier Source: org_study_id