Clinical trial NCT00181233: Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk
Official title: Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sudden Cardiac Death
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Donald W. Reynolds Foundation
First posted: 2005-09-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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)

Brief 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.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: sudden cardiac death
timeFrame: 6 month intervals
measure: cardiovascular death
timeFrame: 6 month intervals
measure: appropriate ICD discharge
timeFrame: 6 month intervals
measure: composite sudden cardiac death and appropriate ICD discharge
timeFrame: 6 month intervals
Secondary outcomes:
measure: heart failure admission
timeFrame: 6 month intervals
Other outcomes:
measure: cardiac transplantation
timeFrame: 6 month intervals
measure: myocardial revascularization
timeFrame: 6 month intervals
measure: left ventricular assist device placement
timeFrame: 6 month intervals
measure: biventricular pacemaker placement
timeFrame: 6 month intervals
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Katherine C Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.