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Clinical Trials/NCT00181233
NCT00181233
Recruiting
N/A

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

Johns Hopkins University1 site in 1 country400 target enrollmentOctober 1, 2003

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sudden Cardiac Death
Sponsor
Johns Hopkins University
Enrollment
400
Locations
1
Primary Endpoint
sudden cardiac death
Status
Recruiting
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2003
End Date
July 1, 2029
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.)

Outcomes

Primary Outcomes

sudden cardiac death

Time Frame: 6 month intervals

cardiovascular death

Time Frame: 6 month intervals

appropriate ICD discharge

Time Frame: 6 month intervals

composite sudden cardiac death and appropriate ICD discharge

Time Frame: 6 month intervals

Secondary Outcomes

  • heart failure admission(6 month intervals)

Study Sites (1)

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