Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

This study has been completed.

Sponsor:

Information provided by:

University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00312624

First received: April 6, 2006

Last updated: June 9, 2011

Last verified: June 2011

History of Changes

Purpose

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.

Condition	Intervention
Cardiomyopathy	Procedure: contrast-enhanced cardiac MRI


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:


Estimated Enrollment:	50
Study Start Date:	April 2006
Study Completion Date:	December 2008

Intervention Details:

MRI of heart with delayed enhancement

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

patients with cardiomyopathy

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312624

Locations


United States, Pennsylvania
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators


Principal Investigator:	Samir Saba, MD	University of Pittsburgh

More Information


Responsible Party:	Samir Saba/Director, Cardiac electrophysiology, UPMC
ClinicalTrials.gov Identifier:	NCT00312624 History of Changes
Other Study ID Numbers:	0602085
Study First Received:	April 6, 2006
Last Updated:	June 9, 2011

Keywords provided by University of Pittsburgh:


ICD implantation cardiac MRI cardiomyopathy	ventricular arrhythmias LVEF 35% or less indication for ICD implantation as part of standard of care

Additional relevant MeSH terms:


Cardiomyopathies Death Death, Sudden, Cardiac Heart Diseases	Cardiovascular Diseases Pathologic Processes Heart Arrest Death, Sudden

ClinicalTrials.gov processed this record on June 22, 2017

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