Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction
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
3 other identifiers
interventional
73
2 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2006
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 31, 2006
CompletedFirst Posted
Study publicly available on registry
April 4, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedDecember 15, 2014
December 1, 2014
March 31, 2006
December 11, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Quantitative measurement of the total area of delayed enhancement
30 min post injection
Secondary Outcomes (5)
Quantitative measures of area of delayed enhancement and signal intensities
At 5, 10 and 20 minutes post injection
Semiquantitative measures of area of delayed enhancement
At 5, 10, 20 and 30 minutes post injection
Presence of delayed enhancement
At 5,10 and 20 minutes post injection
Wall motion endpoints
Pre-injection
Safety
From baseline to 24h follow-up of second imaging
Study Arms (2)
Arm 2
EXPERIMENTALArm 1
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- At least 8 weeks post-documented myocardial infarction (heart attack)
You may not qualify if:
- History of radiation therapy to the chest
- Clinically unstable
- Any contraindication for MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (7)
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Tulsa, Oklahoma, 74133, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Hershey, Pennsylvania, 17033, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15212-4772, United States
Unknown Facility
Buenos Aires, Buenos Aires, C1428BKN, Argentina
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2006
First Posted
April 4, 2006
Study Start
March 1, 2006
Study Completion
September 1, 2006
Last Updated
December 15, 2014
Record last verified: 2014-12