RECRUITING

Left Ventricular Structural Predictors of Sudden Cardiac Death

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

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]

Quick Facts

Study Start:2003-10
Study Completion:2030-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01076660

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * LVEF≤35%, referred clinically for ICD insertion for primary prevention purposes (i.e. no prior history of sustained ventricular arrhythmias)
  2. * Between the ages of 21 and 80 years old
  3. * Permission of the patient's clinical attending physician
  1. * Patients who refuse or are unable to give consent.
  2. * Individuals with contraindications to MRI (i.e. implanted metallic objects such as pre-existing cardiac pacemakers, cerebral clips or indwelling metallic projectiles)
  3. * Minors.
  4. * Pregnant women.
  5. * NYHA Class IV heart failure.
  6. * Chronic renal insufficiency with creatinine clearance\<60 ml/min; acute renal insufficiency of any severity
  7. * Claustrophobia
  8. * Prior adverse reaction to gadolinium-based contrast

Contacts and Locations

Study Contact

Barbara D Butcher, RN
CONTACT
443-287-3472
bbutche1@jhmi.edu

Principal Investigator

Katherine Wu, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Robert G Weiss, MD
STUDY_DIRECTOR
Johns Hopkins University

Study Locations (Sites)

Christiana Care Health Services
Newark, Delaware, 19718
United States
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Katherine Wu, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University
  • Robert G Weiss, MD, STUDY_DIRECTOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2003-10
Study Completion Date2030-06

Study Record Updates

Study Start Date2003-10
Study Completion Date2030-06

Terms related to this study

Keywords Provided by Researchers

  • Ischemic cardiomyopathy
  • Nonischemic cardiomyopathy
  • Implantable cardioverter defibrillator
  • Sudden Cardiac Death
  • Ventricular tachycardia
  • Ventricular fibrillation

Additional Relevant MeSH Terms

  • Ischemic Cardiomyopathy
  • Nonischemic Cardiomyopathy