- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00181233
Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk
January 4, 2024 updated by: Johns Hopkins University
Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death
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.
Study Overview
Status
Recruiting
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Estimated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Barbara Butcher, RN
- Phone Number: 443-287-3472
- Email: bbutche1@jhmi.edu
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins Medical Institutions
-
Contact:
- Tricia Steinberg, RN
- Phone Number: 443-287-3469
- Email: asteinb3@jhmi.edu
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients with contractile dysfunction (EF< or = 35%) on an ischemic or non-ischemic basis undergoing clinically-indicated ICD implantation for primary prevention of sudden cardiac death (SCD)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
sudden cardiac death
Time Frame: 6 month intervals
|
6 month intervals
|
cardiovascular death
Time Frame: 6 month intervals
|
6 month intervals
|
appropriate ICD discharge
Time Frame: 6 month intervals
|
6 month intervals
|
composite sudden cardiac death and appropriate ICD discharge
Time Frame: 6 month intervals
|
6 month intervals
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
heart failure admission
Time Frame: 6 month intervals
|
6 month intervals
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cardiac transplantation
Time Frame: 6 month intervals
|
6 month intervals
|
myocardial revascularization
Time Frame: 6 month intervals
|
6 month intervals
|
left ventricular assist device placement
Time Frame: 6 month intervals
|
6 month intervals
|
biventricular pacemaker placement
Time Frame: 6 month intervals
|
6 month intervals
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine C Wu, MD, Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Samuel TJ, Lai S, Schar M, Wu KC, Steinberg AM, Wei AC, Anderson ME, Tomaselli GF, Gerstenblith G, Bottomley PA, Weiss RG. Myocardial ATP depletion detected noninvasively predicts sudden cardiac death risk in patients with heart failure. JCI Insight. 2022 Jun 22;7(12):e157557. doi: 10.1172/jci.insight.157557.
- Wu KC, Gerstenblith G, Guallar E, Marine JE, Dalal D, Cheng A, Marban E, Lima JA, Tomaselli GF, Weiss RG. Combined cardiac magnetic resonance imaging and C-reactive protein levels identify a cohort at low risk for defibrillator firings and death. Circ Cardiovasc Imaging. 2012 Mar;5(2):178-86. doi: 10.1161/CIRCIMAGING.111.968024. Epub 2012 Jan 20.
- Wu KC, Weiss RG, Thiemann DR, Kitagawa K, Schmidt A, Dalal D, Lai S, Bluemke DA, Gerstenblith G, Marban E, Tomaselli GF, Lima JA. Late gadolinium enhancement by cardiovascular magnetic resonance heralds an adverse prognosis in nonischemic cardiomyopathy. J Am Coll Cardiol. 2008 Jun 24;51(25):2414-21. doi: 10.1016/j.jacc.2008.03.018.
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 Major Dates
Study Start
October 1, 2003
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
July 1, 2029
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimated)
September 16, 2005
Study Record Updates
Last Update Posted (Estimated)
January 8, 2024
Last Update Submitted That Met QC Criteria
January 4, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00037404
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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