check_circleStudy Completed

Myocardial Infarction

Bayer Identifier:

91230

ClinicalTrials.gov Identifier:

NCT00310544

EudraCT Number:

Not Available

EU CT Number:

Not Available
Depiction of delayed enhancement in patients with documented myocardial infarction

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 Years
  • - At least 8 weeks post-documented myocardial infarction (heart attack)
  • - History of radiation therapy to the chest
    - Clinically unstable
    - Any contraindication for MRI

Trial summary

Enrollment Goal
73
Trial Dates
March 2006 - September 2006
Phase
Phase 2
Could I Receive a placebo
No
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Allegheny General HospitalPittsburgh, 15212-4772, United States
Completed
Pennsylvania State University College of MedicineHershey, 17033, United States
Completed
Forsyth Radiologcial Associates, PAWinston-Salem, 27103, United States
Completed
Oklahoma Heart InstituteTulsa, 74133, United States
Completed
University of California-San Diego Medical CenterSan Diego, 92103, United States
Completed
Oregon Health and Science UniversityPortland, 97239, United States
Completed
Centro de Diagnóstico Dr. Enrique RossiBuenos Aires, C1428BKN, Argentina

Primary Outcome

  • Quantitative measurement of the total area of delayed enhancement
    date_rangeTime Frame:
    30 min post injection
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Quantitative measures of area of delayed enhancement and signal intensities
    date_rangeTime Frame:
    At 5, 10 and 20 minutes post injection
    enhanced_encryption
    Safety Issue:
    None
  • Semiquantitative measures of area of delayed enhancement
    date_rangeTime Frame:
    At 5, 10, 20 and 30 minutes post injection
    enhanced_encryption
    Safety Issue:
    None
  • Presence of delayed enhancement
    date_rangeTime Frame:
    At 5,10 and 20 minutes post injection
    enhanced_encryption
    Safety Issue:
    None
  • Wall motion endpoints
    date_rangeTime Frame:
    Pre-injection
    enhanced_encryption
    Safety Issue:
    None
  • Safety
    date_rangeTime Frame:
    From baseline to 24h follow-up of second imaging
    enhanced_encryption
    Safety Issue:
    None

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Randomized
Blinding
Single Blind
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

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