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Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk

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. Identifier: NCT00181233
Recruitment Status : Recruiting
First Posted : September 16, 2005
Last Update Posted : January 30, 2020
Donald W. Reynolds Foundation
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease
Sudden Cardiac 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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death
Study Start Date : October 2003
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Primary Outcome Measures :
  1. sudden cardiac death [ Time Frame: 6 month intervals ]
  2. cardiovascular death [ Time Frame: 6 month intervals ]
  3. appropriate ICD discharge [ Time Frame: 6 month intervals ]
  4. composite sudden cardiac death and appropriate ICD discharge [ Time Frame: 6 month intervals ]

Secondary Outcome Measures :
  1. heart failure admission [ Time Frame: 6 month intervals ]

Other Outcome Measures:
  1. cardiac transplantation [ Time Frame: 6 month intervals ]
  2. myocardial revascularization [ Time Frame: 6 month intervals ]
  3. left ventricular assist device placement [ Time Frame: 6 month intervals ]
  4. biventricular pacemaker placement [ Time Frame: 6 month intervals ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

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.)

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 identifier (NCT number): NCT00181233

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Contact: Barbara Butcher 443-287-3472

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United States, Maryland
Johns Hopkins Medical Institutions Recruiting
Baltimore, Maryland, United States, 21287
Contact: Tricia Steinberg, RN    443-287-3469   
Sponsors and Collaborators
Johns Hopkins University
Donald W. Reynolds Foundation
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Principal Investigator: Katherine C Wu, MD Johns Hopkins University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Johns Hopkins University Identifier: NCT00181233    
Other Study ID Numbers: NA_00037404
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Death, Sudden, Cardiac
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden