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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05982652
Other study ID # 05-2021-293
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2023

Study information

Verified date August 2023
Source Pusan National University Yangsan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In this study, the SCI patients were sub-grouped on the basis of symptoms into symptomatic and asymptomatic groups and measured HRV during resting and tilt up tests to compare their cardiovascular autonomic functions.


Description:

In study protocol and the subjects were asked to lie down quietly for 5 minutes, closing their eyes and avoiding talking, moving hand, legs and body, and coughing during the test. R-R interval and blood pressure were measured beat-to-beat using Finometer® PRO (Finapres Medical Systems, Amsterdam, Netherlands) for 6 minutes each in two positions, supine and 60-degree angle on the tilt table.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date December 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - spinal cord injury with or without OH - aged 19 or older - ASIA Impairment Scale (AIS) A to D - neurological level of injury above T6. Exclusion Criteria: - Those with heart and respiratory diseases, neurological diseases other than SCI - medically unstable states - Those who are taking medications affecting BP that cannot be stopped

Study Design


Locations

Country Name City State
Korea, Republic of Pusan National University Yangsan Hospital, Geumo-ro 20, Mulgeum-eup Yangsan Gyeongnam

Sponsors (1)

Lead Sponsor Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Stampas A, Zhu L, Li S. Heart rate variability in spinal cord injury: Asymptomatic orthostatic hypotension is a confounding variable. Neurosci Lett. 2019 Jun 11;703:213-218. doi: 10.1016/j.neulet.2019.03.020. Epub 2019 Mar 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Differences of heart rate variability between groups (OH vs non-OH, asymptomatic-OH vs symptomatic-OH group) mean HR (heart rate), mean RR(RR interval), RMSSD (mean square of the successive R-R interval differences), SDNN (standard deviation of normal-to-normal interval), LF (low frequency) domain, HF(High frequency) domain at the test time (15minutes)
Primary Logistic regression analysis of heart rate variability variables according to OH and presence of symptom the investigators conducted logistic regression analysis to evaluate the significance and impact of HRV variables associated with orthostatic hypotension and its symptoms in spinal cord injury patients. at the test time (15minutes)
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