Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk

Sudden Cardiac Death Clinical Trial

Official title:

Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00181233
• Other study ID #: NA_00037404
• Status: Recruiting
• 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
• 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.)

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Sudden Cardiac Death

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