Back to resultsDepiction of Delayed Enhancement in Patients With Documented Myocardial Infarction
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Magnevist (Gadopentetate dimeglumine, BAY86-4882)
Magnevist (Gadopentetate dimeglumine, BAY86-4882)
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Infarction
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 2
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Quantitative measurement of the total area of delayed enhancement
Secondary Outcome Measures
Quantitative measures of area of delayed enhancement and signal intensities
Semiquantitative measures of area of delayed enhancement
Presence of delayed enhancement
Wall motion endpoints
Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00310544
Brief Title
Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the dose of drug which is most effective in the delineation of dead heart muscle.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Magnevist (Gadopentetate dimeglumine, BAY86-4882)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Magnevist (Gadopentetate dimeglumine, BAY86-4882)
Intervention Description
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
Primary Outcome Measure Information:
Title
Quantitative measurement of the total area of delayed enhancement
Time Frame
30 min post injection
Secondary Outcome Measure Information:
Title
Quantitative measures of area of delayed enhancement and signal intensities
Time Frame
At 5, 10 and 20 minutes post injection
Title
Semiquantitative measures of area of delayed enhancement
Time Frame
At 5, 10, 20 and 30 minutes post injection
Title
Presence of delayed enhancement
Time Frame
At 5,10 and 20 minutes post injection
Title
Wall motion endpoints
Time Frame
Pre-injection
Title
Safety
Time Frame
From baseline to 24h follow-up of second imaging
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-4772
Country
United States
City
Buenos Aires
ZIP/Postal Code
C1428BKN
Country
Argentina
12. IPD Sharing Statement
Learn more about this trial
Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction
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