Sudden Cardiac DeathNCT00181233
Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk
An observational study of Sudden Cardiac Death, run by Johns Hopkins University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Left ventricular ejection fraction <or = 35%
- Planned implantable cardioverter-defibrillator (ICD) implantation for clinical indications (primary prevention)
Who cannot join
- History of sudden death (secondary prevention)
- Contraindication to undergoing MRI (metallic implant, pacemaker, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287
Tricia Steinberg, RN, 443-287-3469, asteinb3@jhmi.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Sudden Cardiac Death
- Medical subject headings
- Death, Sudden, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
sudden cardiac death
Measured: 6 month intervals
cardiovascular death
Measured: 6 month intervals
appropriate ICD discharge
Measured: 6 month intervals
composite sudden cardiac death and appropriate ICD discharge
Measured: 6 month intervals
Secondary outcomes (1)
heart failure admission
Measured: 6 month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionFeb 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Donald W. Reynolds Foundation
- Responsible party
- Sponsor
- Investigators
- Katherine C Wu, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181233
- Sponsor's protocol ID
- NA_00037404
- Status last verified
- Jan 2026
- First submitted
- 13 Sep 2005
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 35579938Wu 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.
PubMed 22267750Wu 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.
PubMed 18565399
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death
- ClinicalTrials.gov ID
- NCT00181233
- Acronym / sponsor ID
- NA_00037404
- Conditions
- Sudden Cardiac Death
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Donald W. Reynolds Foundation
- Study start
- Oct 2003
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- Left ventricular ejection fraction <or = 35%
- Planned implantable cardioverter-defibrillator (ICD) implantation for clinical indications (primary prevention)
Key exclusion criteria (2 listed)
- History of sudden death (secondary prevention)
- Contraindication to undergoing MRI (metallic implant, pacemaker, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sudden cardiac death
Time frame: 6 month intervals
cardiovascular death
Time frame: 6 month intervals
appropriate ICD discharge
Time frame: 6 month intervals
composite sudden cardiac death and appropriate ICD discharge
Time frame: 6 month intervals
1 secondary outcome
heart failure admission
Time frame: 6 month intervals
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Derived from this study: PubMed 35579938Samuel 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.
- Derived from this study: PubMed 22267750Wu 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.
- Derived from this study: PubMed 18565399Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine C Wu, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Butcher, RN (443-287-3472, bbutche1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sudden cardiac death (time frame: 6 month intervals). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00181233, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.