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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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Technetium Tc99m Tetrofosmin injections

Thallous Chloride T1-201

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The subject is 18 years old or older.
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.
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.
The subject is suspected of or known of having CAD based on the subject's clinical signs, symptoms, or examinations .
The subject is referred for Rest/Stress (exercise or pharmacological) MPS-SPECT for known or suspected CAD (as clinically required).

Exclusion Criteria:

The subject was previously included in this study.
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.
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).
The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month.
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.

Sites / Locations

GE Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Thallous Chloride T1-201

Technetium Tc99m Tetrofosmin injections

Outcomes

Primary Outcome Measures

The diagnostic results ("normal" versus "abnormal") of the dual-isotope and single isotope myocardial SPECT examinations will be compared for equivalence on a subject level for the Uninformed and Informed Analysis Groups.

Secondary Outcome Measures

Full Information

NCT ID

NCT00381316

First Posted

September 25, 2006

Last Updated

December 3, 2007

Sponsor

GE Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT00381316

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

GE Healthcare

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

291 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Thallous Chloride T1-201

Arm Title

Arm Type

Active Comparator

Arm Description

Technetium Tc99m Tetrofosmin injections

Intervention Type

Drug

Intervention Name(s)

Technetium Tc99m Tetrofosmin injections

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Thallous Chloride T1-201

Intervention Description

Myoview SPECT Imaging

Primary Outcome Measure Information:

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The subject is 18 years old or older. 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. 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. The subject is suspected of or known of having CAD based on the subject's clinical signs, symptoms, or examinations . The subject is referred for Rest/Stress (exercise or pharmacological) MPS-SPECT for known or suspected CAD (as clinically required). Exclusion Criteria: The subject was previously included in this study. 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. 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). The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andre Mueller-York

Organizational Affiliation

GE Healthcare

Official's Role

Study Director

Facility Information:

Facility Name

GE Healthcare

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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