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OpenTrials
Completed

NCT Number: NCT00312624

Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

contrast-enhanced cardiac MRI

Procedure

MRI of heart with delayed enhancement

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2006
Study completion
2008
First posted
Apr 10, 2006
Registry last updated
Jun 10, 2011

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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