Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00310544

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 II

MedlinePlus related topics: Heart Attack

Drug Information available for: Gadolinium DTPA

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Subject), Dose Comparison, Crossover Assignment, Safety/Efficacy Study
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

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:	79
Study Start Date:	February 2006
Study Completion Date:	October 2006

Arms	Assigned Interventions
Arm 2: Experimental	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 weight period 2: Magnevist 0.1 mmol/kg body weight
Arm 1: Experimental	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 weight period 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
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

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

Pittsburgh, Pennsylvania, United States, 15212-4772

Hershey, Pennsylvania, United States, 17033
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 marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	91230, DE-03899, 306947
Study First Received:	March 31, 2006
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00310544 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 07, 2009