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Completed

NCT Number: NCT00310544

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnevist (Gadopentetate dimeglumine, BAY86-4882)

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

Primary outcomes

  1. Quantitative measurement of the total area of delayed enhancement

    Time frame: 30 min post injection

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2006
First posted
Apr 4, 2006
Registry last updated
Dec 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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