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

NCT00381316 | Completed Phase 4

• 1 other identifier: 143-002
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

1

ACTIVE COMPARATOR

Thallous Chloride T1-201

Drug: Thallous Chloride T1-201

2

ACTIVE COMPARATOR

Technetium Tc99m Tetrofosmin injections

Drug: Technetium Tc99m Tetrofosmin injections

Interventions

Technetium Tc99m Tetrofosmin injections DRUG

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

2

Thallous Chloride T1-201 DRUG

Myoview SPECT Imaging

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Andre Mueller-York

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 25, 2006
• First Posted: September 27, 2006
• Study Start: July 1, 2006
• Study Completion: December 1, 2006
• Last Updated: December 5, 2007

Record last verified: 2007-11

Locations

US (1)