Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies - Full Text View

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

Genetics Home Reference related topics:

short QT syndrome

MedlinePlus related topics:

Cardiac Arrest Cardiomyopathy

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

Further study details as provided by University of Pittsburgh:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	April 2006
Estimated 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
Genders Eligible for Study:	Both
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

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

Contacts


Contact: Samir Saba, MD	412-647-6272	sabas@upmc.edu

Contact: Pamela M White, RN	412 647-2931	whitepm@upmc.edu

Locations


United States, Pennsylvania
	UPMC Presbyterian Hospital	Recruiting
	Pittsburgh, Pennsylvania, United States, 15213
	Contact: Samir Saba, MD 412-647-6272 sabas@upmc.edu
	Contact: Pamela M White, RN 412 647-2931 whitepm@upmc.edu
	Principal Investigator: Samir Saba, MD
	Principal Investigator: Eathar Razak, MD
	Sub-Investigator: William Barrington, MD
	Sub-Investigator: Raveen Bazaz, MD
	Sub-Investigator: Sandeep Jain, MD
	Sub-Investigator: David Schwartzman, MD
	Sub-Investigator: Susan Brode, MD

Sponsors and Collaborators

University of Pittsburgh

Investigators


Principal Investigator:	Samir Saba, MD	University of Pittsburgh

More Information

Responsible Party:	UPMC ( Samir Saba/Director, Cardiac electrophysiology )
Study ID Numbers:	0602085, 0602085
First Received:	April 6, 2006
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00312624
Health Authority:	United States: Institutional Review Board

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

Study placed in the following topic categories:

Death

Heart Diseases

Death, Sudden

Heart Arrest

Death, Sudden, Cardiac

Cardiomyopathies

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00312624