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Myocardial Perfusion MRI

NCT01490294 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2014-05-22

Study results available
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Summary

The object of this study is to compare four different dosages of Gadavist 1.0 in cardiac Magnetic Resonance Tomography (MRT) imaging with the imaging results of a cardiac SPECT examination in terms of diagnostic quality.

For this purpose Gadavist dosages of 0.01 mmol/kg, 0.025 mmol/kg, 0.05 mmol/kg or 0.1mmol/kg body weight are administered. A study participant receives the respective dose twice i.e. at rest and at stress using Adenosine (which puts circulation into a state of stress similar to that of physical exercise). The time between both injections is 10-15 min.

The total imaging time is about 45 min.

Conditions

  • Myocardial Perfusion Imaging
  • Magnetic Resonance Imaging

Interventions

DRUG

Gadobutrol (Gadavist,Gadovist, BAY86-4875)

0.01 mmol/kg BW (0.01 mL/kg) for stress MRI and 0.01 mmol/kg BW (0.01 mL/kg) for rest MRI (total dose 0.02 mmol/kg)

DRUG

Gadobutrol (Gadavist,Gadovist, BAY86-4875)

0.025 mmol/kg BW (0.025 mL/kg) for stress MRI and 0.025 mmol/kg BW (0.025 mL/kg) for rest MRI (total dose 0.05 mmol/kg)

DRUG

Gadobutrol (Gadavist,Gadovist, BAY86-4875)

0.05 mmol/kg BW (0.05 mL/kg) for stress MRI and 0.05 mmol/kg BW (0.05 mL/kg) for rest MRI (total dose 0.1 mmol/kg)

DRUG

Gadobutrol (Gadavist,Gadovist, BAY86-4875)

0.1 mmol/kg BW (0.1 mL/kg) for stress MRI and 0.1 mmol/kg BW (0.1 mL/kg) for rest MRI (total dose 0.2 mmol/kg)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2006-05-31
Completion
2006-05-31

Countries

  • Austria
  • Germany
  • Poland
  • Switzerland

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01490294 on ClinicalTrials.gov