Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction

Study Description

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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.

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

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	73 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Participant)
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
Study Start Date :	March 2006
Actual Study Completion Date :	September 2006

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Quantitative measurement of the total area of delayed enhancement [ Time Frame: 30 min post injection ]

Secondary Outcome Measures :

1. Quantitative measures of area of delayed enhancement and signal intensities [ Time Frame: At 5, 10 and 20 minutes post injection ]
2. Semiquantitative measures of area of delayed enhancement [ Time Frame: At 5, 10, 20 and 30 minutes post injection ]
3. Presence of delayed enhancement [ Time Frame: At 5,10 and 20 minutes post injection ]
4. Wall motion endpoints [ Time Frame: Pre-injection ]
5. Safety [ Time Frame: From baseline to 24h follow-up of second imaging ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Additional Information:

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Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT00310544 History of Changes
Other Study ID Numbers:	91230; DE-03899; 306947
First Posted:	April 4, 2006
Last Update Posted:	December 15, 2014
Last Verified:	December 2014

Additional relevant MeSH terms:

Infarction; Myocardial Infarction; Ischemia; Pathologic Processes; Necrosis	Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases