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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00181233
Other study ID # NA_00037404
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2003
Est. completion date July 2029

Study information

Verified date January 2024
Source Johns Hopkins University
Contact Barbara Butcher, RN
Phone 443-287-3472
Email bbutche1@jhmi.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date July 2029
Est. primary completion date February 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Johns Hopkins Medical Institutions Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University Donald W. Reynolds Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other cardiac transplantation 6 month intervals
Other myocardial revascularization 6 month intervals
Other left ventricular assist device placement 6 month intervals
Other biventricular pacemaker placement 6 month intervals
Primary sudden cardiac death 6 month intervals
Primary cardiovascular death 6 month intervals
Primary appropriate ICD discharge 6 month intervals
Primary composite sudden cardiac death and appropriate ICD discharge 6 month intervals
Secondary heart failure admission 6 month intervals
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