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NCT01919983 · ClinicalTrials.gov registry record
Inflammation, Cardiac Sympathetic Innervation, and Arrhythmic Sudden Death
A clinical trial, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 28
- Enrollment target
NCT01919983: Completed study, sponsored by Johns Hopkins University.
NCT01919983 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01919983 has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 28 participants
- Enrollment target
Study Summary
Despite pharmacologic advances for the treatment of congestive heart failure (HF), sudden cardiac death (SCD) and pump failure remain the leading causes of mortality in patients with HF. Although, SCD is poorly understood, implantable cardiac defibrillators (ICD) have been shown to be an effective, but costly therapy in preventing SCD. At present, left ventricular systolic dysfunction is our best independent predictor of SCD, but only moderately predicts those patients who will eventually benefit from the placement of an ICD and, in most cases, left ventricular (LV) systolic dysfunction is a non-modifiable risk factor once acquired. As a result, there exists an intensive search for biomarkers that could improve the prediction of SCD and have the potential for risk factor modification. Experimental and clinical evidence has established that inflammation plays a critical role in stable coronary disease, plaque rupture, acute myocardial infarction, heart failure, and SCD. Studies at our institution have demonstrated that elevated levels of hsCRP and Interleukin-6 are predictive of arrhythmic SCD; however, the mechanism of causing this increased risk is unclear. Another well-known risk factor for SCD is abnormal sympathetic innervation. The most robust clinical test of sympathetic innervation to date is Iodine-123 Metaiodobenzylguanidine (MIBG) imaging with gamma scintigraphy. MIBG imaging has emerged as one of our strongest predictors of SCD by detecting sympathetic nervous system abnormalities in patients with HF. Preclinical and clinical evidence suggests that myocardial inflammation adversely affects myocardial innervation. Based on these findings, the investigators hypothesize that elevated levels of inflammatory biomarkers are associated with abnormal sympathetic innervation as measured by MIBG imaging. The investigators aim to establish the strength of this association. This proposal will leverage unique access to the largest, most extensively phenotyped cohor
Primary Outcome
The investigators will determine if inflammation, measured by high sensitivity C-reactive protein is associated with abnormal cardaic sympathetic innervation defined as a heart to mediastinum ratio \< 1.60.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-03 |
| Est. Completion | 2014-09 |
What the finished NCT01919983 record still lists
NCT01919983 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 28 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01919983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01919983 about?
NCT01919983 is a clinical study titled "Inflammation, Cardiac Sympathetic Innervation, and Arrhythmic Sudden Death". Despite pharmacologic advances for the treatment of congestive heart failure (HF), sudden cardiac death (SCD) and pump failure remain the leading causes of mortality in patients with HF. Although, SCD is poorly understood, implantable cardiac defibrillators (ICD) have been shown to be an effective, ...
What is the current status of trial NCT01919983?
This trial is currently completed. The enrollment target is 28 participants. The study started on 2012-03. Estimated completion is 2014-09.
Who is sponsoring clinical trial NCT01919983?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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