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Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

NCT ID: NCT00312624

Last Updated: 2011-06-10

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

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-12-31

Brief Summary

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This is a pilot study to find a correlation between MRI and ICD therapy in patients with known cardiomyopathies, aiming to determine if cardiac scarring identified by MRI correlates with ventricular arrhythmias and the occurrence of ICD therapy.

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Detailed Description

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This is an observational study over a 3 year period of 50 patients with known cardiomyopathy and LVEF of 35% or less who will have ICD implantation as part of their standard of care. All subjects will undergo a contrast-enhanced cardiac MRI using gadolinium to determine the morphological characteristics of their left ventricle prior to ICD implant. Subjects will not be offered sedation to minimize risk, thus those suffering from claustrophobia will be excluded or dropped from participation. MRI will be evaluated, and subjects will be followed during standard of care device interrogations for 12 months after implant.

Conditions

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Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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contrast-enhanced cardiac MRI

MRI of heart with delayed enhancement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* at least 18 years of age
* cardiomyopathy with LVEF 35% or less
* indication for ICD implantation
* able to provide informed consent

Exclusion Criteria

* prior device implantation
* contraindication for MRI (i.e., metallic foreign body)
* claustrophobia
* pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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UPMC

Principal Investigators

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Samir Saba, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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0602085

Identifier Type: -

Identifier Source: secondary_id

0602085

Identifier Type: -

Identifier Source: org_study_id

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