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Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction

NCT ID: NCT00310544

Last Updated: 2014-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 2

Group Type EXPERIMENTAL

Magnevist (Gadopentetate dimeglumine, BAY86-4882)

Intervention Type DRUG

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

Arm 1

Group Type EXPERIMENTAL

Magnevist (Gadopentetate dimeglumine, BAY86-4882)

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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San Diego, California, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Tulsa, Oklahoma, United States

Site Status

Portland, Oregon, United States

Site Status

Hershey, Pennsylvania, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Buenos Aires, Buenos Aires, Argentina

Site Status

Countries

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United States Argentina

Other Identifiers

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DE-03899

Identifier Type: -

Identifier Source: secondary_id

306947

Identifier Type: -

Identifier Source: secondary_id

91230

Identifier Type: -

Identifier Source: org_study_id