Skin Sympathetic Nerve Activity and Sympathetic Tone

NCT03243448 | Enrolling By Invitation

• 1 other identifier: KMU-DK106011
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

There are many sympathetic hyperactivity diseases in the investigators' clinical practice. However, the conventional method to measure the sympathetic nerve activity had many limitations such as clinical application, data interpretation and even therapeutic manipulation. Therefore the investigators would like to develop a non-invasive method to record the sympathetic nerve activity in the investigators' study that can help gathering the sympathetic nerve activity easily in the investigators' daily clinical situation. By the determination of sympathetic nerve activity status, the health caregiver can understand the disease more.

Conditions

Nerve; Disorder, Sympathetic; Healthy

Outcome Measures

Primary Outcomes (1)

• Skin Sympathetic Nerve Activity

  The Sympathetic Nerve Activity Recording from the skin of the subjects in the day time.

  12 hours

Secondary Outcomes (3)

• ventricular arrhythmia

  24 to 72 hours

• Mortality

  1 to 12 months

• Morbidity

  1 to 12 months

Study Arms (2)

The general public

people between 20-85 years old, without sympathetic hyperactivity disease

Sympathetic hyperactivity diseases

Sympathetic hyperactivity diseases included: hypertension, heart failure atherosclerotic diseases, arrhythmias, cardiomyopathy, pulmonary hypertension, chronic obstructive pulmonary disease, sleep apnea, pulmonary embolism, hepatitis, liver cirrhosis, hepatopulmonary syndrome, hepatorenal syndrome, renal failure, nephritis, irritable bowel syndrome.

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects who are eligible to the inclusion criteria and admitted to the investigators' ward, visited the investigators' outpatient clinic or health checkup center will be enrolled in the investigators' study.

You may qualify if:

• Sympathetic hyperactivity diseases included: hypertension, heart failure atherosclerotic diseases, arrhythmias, cardiomyopathy, pulmonary hypertension, chronic obstructive pulmonary disease, sleep apnea, pulmonary embolism, hepatitis, liver cirrhosis, hepatopulmonary syndrome, hepatorenal syndrome, renal failure, nephritis, irritable bowel syndrome.
• Healthy Volunteers

You may not qualify if:

• Pregnant

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Related Publications (6)

• Shen MJ, Coffey AC, Straka S, Adams DE, Wagner DB, Kovacs RJ, Clark M, Shen C, Chen LS, Everett TH 4th, Lin SF, Chen PS. Simultaneous recordings of intrinsic cardiac nerve activity and skin sympathetic nerve activity from human patients during the postoperative period. Heart Rhythm. 2017 Nov;14(11):1587-1593. doi: 10.1016/j.hrthm.2017.06.030. Epub 2017 Jun 23.

  PMID: 28648667 RESULT

• Everett TH 4th, Doytchinova A, Cha YM, Chen PS. Recording sympathetic nerve activity from the skin. Trends Cardiovasc Med. 2017 Oct;27(7):463-472. doi: 10.1016/j.tcm.2017.05.003. Epub 2017 May 10.

  PMID: 28619579 RESULT

• Uradu A, Wan J, Doytchinova A, Wright KC, Lin AYT, Chen LS, Shen C, Lin SF, Everett TH 4th, Chen PS. Skin sympathetic nerve activity precedes the onset and termination of paroxysmal atrial tachycardia and fibrillation. Heart Rhythm. 2017 Jul;14(7):964-971. doi: 10.1016/j.hrthm.2017.03.030. Epub 2017 Mar 24.

  PMID: 28347833 RESULT

• Doytchinova A, Hassel JL, Yuan Y, Lin H, Yin D, Adams D, Straka S, Wright K, Smith K, Wagner D, Shen C, Salanova V, Meshberger C, Chen LS, Kincaid JC, Coffey AC, Wu G, Li Y, Kovacs RJ, Everett TH 4th, Victor R, Cha YM, Lin SF, Chen PS. Simultaneous noninvasive recording of skin sympathetic nerve activity and electrocardiogram. Heart Rhythm. 2017 Jan;14(1):25-33. doi: 10.1016/j.hrthm.2016.09.019. Epub 2016 Sep 23.

  PMID: 27670627 RESULT

• Tang CL, Tsai WC, Lee JY, Wang YK, Chen YH, Liu YW, Lin MC, Fang PT, Huang YL, Wu IC. Higher pre-treatment skin sympathetic nerve activity and elevated resting heart rate after chemoradiotherapy predict worse esophageal cancer outcomes. BMC Cancer. 2022 Oct 22;22(1):1086. doi: 10.1186/s12885-022-10180-8.

  PMID: 36271384 DERIVED

• Huang TC, Lin SJ, Chen CJ, Jhuo SJ, Chang CW, Lin SC, Chi NY, Chou LF, Tai LH, Liu YH, Lin TH, Liao WS, Kao PH, Cheng MC, Hsu PC, Lee CS, Lin YH, Lee HC, Lu YH, Yen HW, Lin TH, Su HM, Lai WT, Dai CY, Lee CH, Chen PS, Lin SF, Tsai WC. Skin sympathetic nerve activity and ventricular arrhythmias in acute coronary syndrome. Heart Rhythm. 2022 Oct;19(10):1613-1619. doi: 10.1016/j.hrthm.2022.04.031. Epub 2022 May 5.

  PMID: 35525422 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: August 9, 2017
• Study Start: August 1, 2016
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: October 4, 2023

Record last verified: 2023-10