Skin Sympathetic Nerve Activity and Cardiac Arrhythmias
Public ClinicalTrials.gov record NCT02939469. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
STTR Phase II : Skin Sympathetic Nerve Activity and Cardiac Arrhythmias
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Since the invention of electrocardiogram (ECG), ECG has been an important part of clinical practice. A primary reason for the popularity of the ECG is that it is non-invasive and can be performed in any patient by placing electrodes on the skin. The present methods of ECG recording focus on detecting electrical signals from the heart. the investigators propose that with high frequency sampling and high pass filtering, the investigators can also record SNA from the skin. The somata of the subcutaneous sympathetic nerves on the skin are located at the ipsilateral cervical and stellate ganglia. Because the left stellate ganglion nerve activity (SGNA) is known to trigger cardiac arrhythmias, including AF, VF and VF, It is possible that skin SNA can also be used for arrhythmia prediction. the investigators tested that hypothesis in our preclinical studies (supported by R01 HL71140) using canine models. The results showed that subcutaneous nerve activity (SCNA) recorded with implanted electrodes can be used to estimate stellate ganglion nerve activity(SGNA) in normal dogs and in a canine model of ventricular arrhythmia and sudden death. the investigators also showed that SCNA is more accurate than heart rate variability in estimating cardiac sympathetic tone in ambulatory dogs with myocardial infarction.Therefore, SKNA and SCNA may be useful in estimating cardiac sympathetic tone. In addition to studying the autonomic mechanisms of cardiac arrhythmia, these new methods may have broad application in studying both cardiac and non-cardiac diseases. For example, sympathetic tone is important in the pathogenesis of heart failure, atherosclerosis, peripheral neuropathies, epilepsy, vasovagal syncope, renal failure, hypertension and many others diseases. Direct SKNA and SCNA recording may provide new approaches to study the mechanisms of these common diseases. SKNA recording may also have immediate clinical applications by assisting in the diagnosis and treatment of hyperhidrosis (sweaty palms), paralysis, stroke, diabetes, and neuromuscular diseases. It may be used to assist biofeedback monitoring performed by neurologists to control neuropsychiatric disorders. Because of these potential clinical and commercial applications, the investigators propose that this research project is significant. b. Innovation * Using conventional electrodes on the skin to record SNA. The neuECG utilizes the conventional skin electrodes that are widely used in health care facilities. Skin SNA had been recorded using microneurography techniques, and had been estimated using cutaneous blood flow (vasodilator responses) skin temperature, skin conductance and sweat release. However, microneurography cannot be used in ambulatory patients. The other methods are not direct measurements of SNA. neuECG is the first method that can directly and non-invasively measure the SNA from the skin. * Automated real-time signal processing. the investigators will develop signal processing software to automatically eliminate noise, such as that generated by muscle contraction, electrical appliances, body motion, respiration, and radiofrequency signals. The remaining signals are then processed to separately display in real time to provide health care providers a new method to instantly estimate sympathetic tone. The ECG signals are used for automated arrhythmia detection while the SNA signals are available for risk stratification. This approach allows us to improve and broaden the clinical application of Einthoven's original invention by simultaneous detecting ECG and SNA from the skin. * SKNA patterns as new biomarkers. the investigators have identified unique SKNA patterns that precede the onset of human AF. If proven correct by Specific Aim 3, this new biomarker can help physicians to estimate the arrhythmia risk and to predict the efficacy of catheter ablation for AF.
Study identification
- NCT ID
- NCT02939469
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2016
- Primary completion
- Oct 31, 2018
- Completion
- Oct 31, 2018
- Last update posted
- Jun 13, 2019
2016 – 2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02939469, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 13, 2019 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02939469 live on ClinicalTrials.gov.