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Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk

Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00181233
Enrollment
400
Registered
2005-09-16
Start date
2003-10-31
Completion date
2029-07-31
Last updated
2026-01-14

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

Conditions

Sudden Cardiac Death

Brief summary

Sudden cardiac death is a tragic event that strikes all age groups and is unfortunately increasing in prevalence. Because it is difficult to predict those at highest risk, this study is designed to test the hypothesis that new imaging techniques (magnetic resonance imaging \[MRI\] and computed tomography \[CT\]) are useful for identifying factors which put people at high risk for sudden death.

Detailed description

Some people with heart disease and a weak heart muscle experience abnormal electrical activity of the heart that may predispose them to sudden death. In light of this risk, it has been recommended that such patients undergo implantation of an implantable cardioverter defibrillator (ICD). Your doctors have determined that you are such a patient and are to undergo implantation of an ICD. It is unclear who among the many patients who undergo ICD implantation for this reason are at greatest risk of sudden death and therefore require electrical response from their ICD. This research is being done to determine whether new imaging tests, such as magnetic resonance imaging (MRI) or multi-detector computed tomography (MDCT), can be used to predict who is at highest risk of sudden death and require electrical response from their ICD.

Interventions

None listed

Sponsors

Johns Hopkins University
Lead SponsorOTHER
Donald W. Reynolds Foundation
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* Left ventricular ejection fraction \<or = 35% * Planned implantable cardioverter-defibrillator (ICD) implantation for clinical indications (primary prevention)

Exclusion criteria

* History of sudden death (secondary prevention) * Contraindication to undergoing MRI (metallic implant, pacemaker, etc.)

Design outcomes

Primary

MeasureTime frame
sudden cardiac death6 month intervals
composite sudden cardiac death and appropriate ICD discharge6 month intervals
appropriate ICD discharge6 month intervals
cardiovascular death6 month intervals

Secondary

MeasureTime frame
heart failure admission6 month intervals

Other

MeasureTime frame
cardiac transplantation6 month intervals
biventricular pacemaker placement6 month intervals
left ventricular assist device placement6 month intervals
myocardial revascularization6 month intervals

Countries

United States

Contacts

Primary ContactBarbara Butcher, RN
bbutche1@jhmi.edu443-287-3472

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026