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Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00312624
Enrollment
50
Registered
2006-04-10
Start date
2006-04-30
Completion date
2008-12-31
Last updated
2011-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy

Keywords

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

Brief summary

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.

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.

Interventions

PROCEDUREcontrast-enhanced cardiac MRI

MRI of heart with delayed enhancement

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026