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Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk

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ClinicalTrials.gov Identifier: NCT00181233
Recruitment Status : Recruiting
First Posted : September 16, 2005
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
Donald W. Reynolds Foundation
Information provided by (Responsible Party):
Robert G. Weiss, Johns Hopkins University

September 13, 2005
September 16, 2005
June 28, 2017
October 2003
June 2019   (Final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00181233 on ClinicalTrials.gov Archive Site
heart failure admission [ Time Frame: 6 month intervals ]
Not Provided
  • cardiac transplantation [ Time Frame: 6 month intervals ]
  • myocardial revascularization [ Time Frame: 6 month intervals ]
  • left ventricular assist device placement [ Time Frame: 6 month intervals ]
  • biventricular pacemaker placement [ Time Frame: 6 month intervals ]
Not Provided
 
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
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.
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.
Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients with contractile dysfunction (EF<45%) on an ischemic or non-ischemic basis undergoing clinically-indicated ICD implantation for primary prevention of sudden cardiac death (SCD)
Sudden Cardiac Death
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Not Provided
July 2020
June 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Left ventricular ejection fraction <45%
  • 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.)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Robert G. Weiss, MD 410-955-1703 rweiss@jhmi.edu
United States
 
 
NCT00181233
JHU Reynolds P2
No
Not Provided
Plan to Share IPD: No
Robert G. Weiss, Johns Hopkins University
Johns Hopkins University
Donald W. Reynolds Foundation
Principal Investigator: Robert G. Weiss, MD Johns Hopkins University
Johns Hopkins University
June 2017