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Status:

COMPLETED

A Study of Gadodiamide Injection in Myocardial Perfusion Magnetic Resonance Imaging

Lead Sponsor:

Amersham Buchler, GmbH & Co KG

Collaborating Sponsors:

Beacon Bioscience, Inc.

The Cleveland Clinic

Conditions:

Coronary Artery Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The purpose of this study is to determine how well perfusion cardiac magnetic resonance (MR) imaging is able to detect certain heart abnormalities, such as a coronary artery narrowing. To this purpos...

Detailed Description

This study is a multicentre, open label, phase III study in adult subjects designed to show that Gd-DTPA-BMA (a conventional MR contrast medium = OMNISCAN) enhanced myocardial MR perfusion imaging is ...

Eligibility Criteria

Inclusion

  • The subject is a man or woman and is 18 years of age or older.
  • For women of childbearing potential, the results of a urine or serum human chorionic gonadotropin (beta-HCG) pregnancy test, done at screening (with the result known before investigational product administration), must be negative. Only those women who are surgically sterile (have had a documented bilateral oophorectomy and/or documented hysterectomy) or postmenopausal (cessation of menses for more than 1 year) will be allowed to enrol in the study without a pregnancy test at screening.
  • The subject is conscious and able to comply with study procedures.
  • Written, informed consent is obtained.
  • The subject is suspected, as a results of their clinical signs and symptoms, of having CAD (most subjects will probably be included using these criteria).
  • The subject is referred to a quantitative CXA for known or suspected CAD or has undergone quantitative CXA within 4 weeks prior to MRI without any intervention or change of symptoms since the CXA examination.
  • The subject is referred for a SPECT for a functional evaluation of myocardial perfusion or has undergone SPECT within 4 weeks prior to MRI without any intervention, or change in symptoms, between the 2 examinations (the findings of SPECT will not be taken into account for inclusion purposes).

Exclusion

  • The subject is lactating.
  • The subject is pregnant as defined by a urine or serum beta-HCG pregnancy test obtained within the 24 hours before dosing.
  • The subject was previously included in this study.
  • The subject received an investigational product in the 30 days before or will receive one during or in the 30 days after investigational product administration.
  • The subject has known allergies or a contra-indication to the investigational product.
  • The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month.
  • The subject received or is scheduled to receive an MRI contrast medium (other than the investigational product) within 24 hours prior to or in the 24 hours following the investigational product administration.
  • The subject received or is scheduled to receive an X-ray contrast medium within 12 hours prior to or 12 hours following the investigational product administration.
  • The subject received or is scheduled to receive a SPECT radiotracer within 24 hours prior to or 24 hours following the investigational product administration.
  • The subject received or is scheduled to receive a stress examination (other than the MR stress examination in this study) within 24 hours prior to or 24 hours following the investigational product administration.
  • The subject has experienced a myocardial infarction within the last 14 days.
  • The subject has experienced more than 1 previous myocardial infarction.
  • The subject has a bypass graft.
  • The subject has second or third degree atrioventricular block, sick sinus syndrome or a symptomatic bradycardia.
  • The subject suffers from asthma, bronchospasms or obstructive pulmonary disease.
  • The subject has severe hypotension (\<90 mm Hg systolic).
  • The subject has unstable angina pectoris.
  • The subject has a decompensated congestive cardiac failure.
  • The subject's ECG shows a prolonged QT interval.
  • The subject has a contra-indication for MRI according to clinical guidelines, local regulations or manufacturer's recommendations.
  • The subject has cardiac arrhythmia considered by the investigator to be of a type or of a sufficient degree to make the subject unsuitable for the study.
  • The subject has consumed coffee, tea, coke, chocolate or other caffeinated beverages in the last 24 hours before the adenosine administration.

Key Trial Info

Start Date :

July 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2004

Estimated Enrollment :

533 Patients enrolled

Trial Details

Trial ID

NCT00977093

Start Date

July 1 2003

End Date

June 1 2004

Last Update

September 15 2009

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