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NCT00310544 Clinical Trial

Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:
Multicenter, Single-blind, Randomized, Intraindividual Study of the Safety and Efficacy of Magnevist Gadopentetate Dimeglumine (Magnevist® Injection) at 0.1 and 0.2 mmol/kg for the Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00310544
Other study ID # 91230
Secondary ID DE-03899306947
Status Completed
Phase Phase 2
First received March 31, 2006
Last updated December 11, 2014
Start date March 2006
Est. completion date September 2006

Study information
Verified date December 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the dose of drug which is most effective in the delineation of dead heart muscle.

Description:

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- At least 8 weeks post-documented myocardial infarction (heart attack)

Exclusion Criteria:

- History of radiation therapy to the chest

- Clinically unstable

- Any contraindication for MRI

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Magnevist (Gadopentetate dimeglumine, BAY86-4882)
One intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days.period1:Magnevist 0.1 mmol/kg body weightperiod 2: Magnevist 0.2 mmol/kg body weight
• Magnevist (Gadopentetate dimeglumine, BAY86-4882)
One intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days.period 1: Magnevist 0.2 mmol/kg body weightperiod 2: Magnevist 0.1 mmol/kg body weight

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quantitative measurement of the total area of delayed enhancement 30 min post injection
Secondary Quantitative measures of area of delayed enhancement and signal intensities At 5, 10 and 20 minutes post injection
Secondary Semiquantitative measures of area of delayed enhancement At 5, 10, 20 and 30 minutes post injection
Secondary Presence of delayed enhancement At 5,10 and 20 minutes post injection
Secondary Wall motion endpoints Pre-injection
Secondary Safety From baseline to 24h follow-up of second imaging
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