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NCT Number: NCT00181233

Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk

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.

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Key information

Conditions

Sudden Cardiac Death Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Tricia Steinberg, RN

CONTACT

[email protected]

443-287-3469

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  1. sudden cardiac death

    Time frame: 6 month intervals

  2. cardiovascular death

    Time frame: 6 month intervals

  3. appropriate ICD discharge

    Time frame: 6 month intervals

  4. composite sudden cardiac death and appropriate ICD discharge

    Time frame: 6 month intervals

Secondary outcomes

  1. heart failure admission

    Time frame: 6 month intervals

Other outcomes

  1. cardiac transplantation

    Time frame: 6 month intervals

  2. myocardial revascularization

    Time frame: 6 month intervals

  3. left ventricular assist device placement

    Time frame: 6 month intervals

  4. biventricular pacemaker placement

    Time frame: 6 month intervals

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Butcher, RN

CONTACT

[email protected]

443-287-3472

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Donald W. Reynolds Foundation

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2028
Study completion
2029
First posted
Sep 16, 2005
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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