Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT00181233

Collaborator

Donald W. Reynolds Foundation (Other)

400

Enrollment

Location

249

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Oct 1, 2003

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Outcome Measures

Primary Outcome Measures

sudden cardiac death [6 month intervals]
cardiovascular death [6 month intervals]
appropriate ICD discharge [6 month intervals]
composite sudden cardiac death and appropriate ICD discharge [6 month intervals]

Secondary Outcome Measures

heart failure admission [6 month intervals]

Other Outcome Measures

cardiac transplantation [6 month intervals]
myocardial revascularization [6 month intervals]
left ventricular assist device placement [6 month intervals]
biventricular pacemaker placement [6 month intervals]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Medical Institutions	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

Johns Hopkins University
Donald W. Reynolds Foundation

Investigators

Principal Investigator: Katherine C Wu, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT00181233

Other Study ID Numbers:

NA_00037404

First Posted:

Sep 16, 2005

Last Update Posted:

Jun 9, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Death, Sudden, Cardiac

Death

Study Results

No Results Posted as of Jun 9, 2022