Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Johns Hopkins University
Sponsor:
Collaborator:
Donald W. Reynolds Foundation
Information provided by (Responsible Party):
Robert G. Weiss, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181233
First received: September 13, 2005
Last updated: April 1, 2013
Last verified: April 2013
  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: 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 Johns Hopkins University:

Primary Outcome Measures:
  • sudden cardiac death [ Time Frame: 6 month intervals ] [ Designated as safety issue: No ]
  • cardiovascular death [ Time Frame: 6 month intervals ] [ Designated as safety issue: No ]
  • appropriate ICD discharge [ Time Frame: 6 month intervals ] [ Designated as safety issue: No ]
  • composite sudden cardiac death and appropriate ICD discharge [ Time Frame: 6 month intervals ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • heart failure admission [ Time Frame: 6 month intervals ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • cardiac transplantation [ Time Frame: 6 month intervals ] [ Designated as safety issue: No ]
  • myocardial revascularization [ Time Frame: 6 month intervals ] [ Designated as safety issue: No ]
  • left ventricular assist device placement [ Time Frame: 6 month intervals ] [ Designated as safety issue: No ]
  • biventricular pacemaker placement [ Time Frame: 6 month intervals ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2003
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Johns Hopkins University

Additional 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
Study First Received: September 13, 2005
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014