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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: December 11, 2014
Last verified: December 2014
History of Changes
  Purpose
The purpose of this study is to determine the dose of drug which is most effective in the delineation of dead heart muscle.

Condition Intervention Phase
Myocardial Infarction
 Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882)
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Quantitative measurement of the total area of delayed enhancement [ Time Frame: 30 min post injection ]

Secondary Outcome Measures:
  • 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 ]
Enrollment: 73
Study Start Date: March 2006
Study Completion Date: September 2006
Arms Assigned Interventions
Experimental: Arm 2 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 1 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

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.
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310544

Locations
United States, California
San Diego, California, United States, 92103
United States, North Carolina
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Tulsa, Oklahoma, United States, 74133
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Pittsburgh, Pennsylvania, United States, 15212-4772
Argentina
Buenos Aires, Argentina, C1428BKN
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to Bayer Healthcare products.  This link exits the ClinicalTrials.gov site

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00310544     History of Changes
Other Study ID Numbers: 91230  DE-03899  306947 
Study First Received: March 31, 2006
Last Updated: December 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 26, 2016