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Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk

This study is currently recruiting participants.
Verified June 2017 by Robert G. Weiss, Johns Hopkins University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00181233
First Posted: September 16, 2005
Last Update Posted: June 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Donald W. Reynolds Foundation
Information provided by (Responsible Party):
Robert G. Weiss, Johns Hopkins University
  Purpose
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.

Condition
Sudden Cardiac Death

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death

Further study details as provided by Robert G. Weiss, Johns Hopkins University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • heart failure admission [ Time Frame: 6 month intervals ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: October 2003
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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)
Criteria

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.)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181233


Contacts
Contact: Robert G. Weiss, MD 410-955-1703 rweiss@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Medical Institutions Recruiting
Baltimore, Maryland, United States, 21287
Contact: Tricia Steinberg, RN    443-287-3469    asteinb3@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Donald W. Reynolds Foundation
Investigators
Principal Investigator: Robert G. Weiss, MD Johns Hopkins University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert G. Weiss, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00181233     History of Changes
Other Study ID Numbers: JHU Reynolds P2
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Death
Death, Sudden, Cardiac
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden