Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00310544
First received: March 31, 2006
Last updated: October 10, 2013
Last verified: October 2013

March 31, 2006
October 10, 2013
February 2006
Not Provided
Quantitative measurement of the total area of delayed enhancement [ Time Frame: 30 min post injection ]
Location and extent of myocardial infarction
Complete list of historical versions of study NCT00310544 on ClinicalTrials.gov Archive Site
  • Quantitative measures of area of delayed enhancement and signal intensities [ Time Frame: At 5, 10 and 20 minutes post injection ]
  • Semiquantitative measures of area of delayed enhancement [ Time Frame: At 5, 10, 20 and 30 minutes post injection ]
  • Presence of delayed enhancement [ Time Frame: At 5,10 and 20 minutes post injection ]
  • Wall motion endpoints [ Time Frame: Pre-injection ]
  • Safety [ Time Frame: From baseline to 24h follow-up of second imaging ]
  • Inter- and intra-rater variability
  • Change in wall motion after revascularization
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Myocardial Infarction
  • 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
  • Drug: 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
  • Experimental: Arm 2
    Intervention: Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882)
  • Experimental: Arm 1
    Intervention: Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
October 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina
 
NCT00310544
91230, DE-03899, 306947
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP