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Left Ventricular Structural Predictors of Sudden Cardiac Death

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ClinicalTrials.gov Identifier: NCT01076660
Recruitment Status : Recruiting
First Posted : February 26, 2010
Last Update Posted : December 8, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Sudden cardiac death (SCD) poses a significant health care challenge with high annual incidence and low survival rates. Implantable cardioverter defibrillators (ICDs) prevent SCD in patients with poor heart function. However, the critical survival benefit afforded by the devices is accompanied by short and long-term complications and a high economic burden. Moreover, in using current practice guidelines of reduced heart function, specifically left ventricular ejection fraction (LVEF)≤35%, as the main determining factor for patient selection, only a minority of patients actually benefit from ICD therapy (<25% in 5 years). There is an essential need for more robust diagnostic approaches to SCD risk stratification.

This project examines the hypothesis that structural abnormalities of the heart itself, above and beyond global LV dysfunction, are important predictors of SCD risk since they indicate the presence of the abnormal tissue substrate required for the abnormal electrical circuits and heart rhythms that actually lead to SCD. Information about the heart's structure will be obtained from cardiac magnetic resonance imaging and used in combination with a number of other clinical risk factors to see if certain characteristics can better predict patients at risk for SCD.


Condition or disease
Ischemic Cardiomyopathy Nonischemic Cardiomyopathy

Detailed Description:

Sudden cardiac death (SCD) poses a significant health care challenge with high annual incidence and low survival rates. Implantable cardioverter defibrillators (ICDs) prevent SCD in patients with left ventricular (LV) systolic dysfunction. However, the critical survival benefit afforded by the devices is accompanied by short and long-term complications and a high economic burden. Moreover, in using current practice guidelines of LV ejection fraction (LVEF)≤35% as the main determining factor for patient selection, only a minority of patients actually benefit from ICD therapy (<25% in 5 years). There is an essential need for more robust diagnostic approaches to SCD risk stratification.

This project examines the hypothesis that LV structural abnormalities above and beyond global LV dysfunction are important predictors of SCD risk since they indicate the presence of abnormal pathophysiologic substrate required for the ventricular arrhythmogenicity leading to SCD. This premise is supported by pre-clinical models and limited patient cohort studies examining the contribution of individual LV structural indices. However, there has been no prospective study of primary prevention ICD candidates in sufficiently large numbers to investigate the incremental value of a comprehensive assessment of LV structure on SCD risk over and above that of LVEF and readily available demographic and clinical variables.

LV structure can be quantified in detail using cardiac magnetic resonance imaging with late gadolinium enhancement (CMR-LGE). Specifically, accurate assessment of global LV function, volumes, mass, geometry, and infarct/scar characteristics are feasible and obtainable clinically in a single examination. We aim to examine whether or not any of these CMR indices or combination of indices are better able to discriminate between patients with high versus low susceptibility to SCD within the broader population of reduced LVEF patients. If the results of these studies demonstrate that LV structure is an important prognostic risk factor, it may be then be possible to more specifically focus ICD therapy to those who are most likely to benefit and avoid unnecessary device implantations.


Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Left Ventricular Structural Predictors of Sudden Cardiac Death [Substudy of: Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death, See Also NCT000181233]
Study Start Date : October 2003
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Composite SCD outcomes [ Time Frame: Every 6 months for 5 years ]
    The first occurrence of an adjudicated appropriate ICD firing for ventricular tachycardia/ventricular fibrillation or cardiac death not treated by the ICD.


Secondary Outcome Measures :
  1. Composite cardiac outcomes [ Time Frame: Every 6 months for 5 years ]
    The first occurrence of an adjudicated appropriate ICD firing for ventricular tachycardia/ventricular fibrillation, hospitalization for heart failure or cardiac death.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with LV ejection fraction (LVEF) ≤35% of ischemic or nonischemic etiology (as measured by a clinical echocardiogram, ventriculogram, or radionuclide study) referred clinically for ICD insertion for primary prevention purposes (i.e. no prior history of sustained ventricular arrhythmias)
Criteria

Inclusion Criteria:

  • LVEF≤35%, referred clinically for ICD insertion for primary prevention purposes (i.e. no prior history of sustained ventricular arrhythmias)
  • Between the ages of 21 and 80 years old
  • Permission of the patient's clinical attending physician

Exclusion Criteria:

  • Patients who refuse or are unable to give consent.
  • Individuals with contraindications to MRI (i.e. implanted metallic objects such as pre-existing cardiac pacemakers, cerebral clips or indwelling metallic projectiles)
  • Minors.
  • Pregnant women.
  • NYHA Class IV heart failure.
  • Chronic renal insufficiency with creatinine clearance<60 ml/min; acute renal insufficiency of any severity
  • Claustrophobia
  • Prior adverse reaction to gadolinium-based contrast
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): NCT01076660


Contacts
Contact: Jeannette Walker, RN 410-502-7310 jhoefli1@jhmi.edu

Locations
United States, Delaware
Christiana Care Health Services Active, not recruiting
Newark, Delaware, United States, 19718
United States, Maryland
Johns Hopkins Medical Institutions Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Katherine Wu, MD         
Sponsors and Collaborators
Johns Hopkins University
Donald W. Reynolds Foundation
Christiana Care Health Services
Investigators
Principal Investigator: Katherine Wu, MD Johns Hopkins University
Study Director: Robert G Weiss, MD Johns Hopkins University
More Information

Publications:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01076660     History of Changes
Other Study ID Numbers: Reynolds03073103
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
Ischemic cardiomyopathy
Nonischemic cardiomyopathy
Implantable cardioverter defibrillator
Sudden Cardiac Death
Ventricular tachycardia
Ventricular fibrillation

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