Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk

This study is currently recruiting participants.

Verified by Johns Hopkins University, May 2008

Sponsors and Collaborators:	Johns Hopkins University Donald W. Reynolds Foundation
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00181233

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

MedlinePlus related topics: Cardiac Arrest

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective

Further study details as provided by Johns Hopkins University:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	400
Study Start Date:	October 2003
Estimated Study Completion Date:	July 2011

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

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: Scherer Sanders, PhD 443-287-7463 ssander4@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 indexed to this study:

Wu KC, Weiss RG, Thiemann DR, Kitagawa K, Schmidt A, Dalal D, Lai S, Bluemke DA, Gerstenblith G, Marbán E, Tomaselli GF, Lima JA. Late gadolinium enhancement by cardiovascular magnetic resonance heralds an adverse prognosis in nonischemic cardiomyopathy. J Am Coll Cardiol. 2008 Jun 24;51(25):2414-21.

Responsible Party:	Johns Hopkins University School of Medicine ( Robert G. Weiss, M.D. )
Study ID Numbers:	JHU Reynolds P2
Study First Received:	September 13, 2005
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00181233
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Death
Heart Diseases
Death, Sudden
Heart Arrest
Death, Sudden, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009