Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06447896 |
Other study ID # |
CARTS20210908 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 11, 2011 |
Est. completion date |
August 12, 2022 |
Study information
Verified date |
June 2024 |
Source |
REEM (Shenzhen) Healthcare Co., Ltd |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This is a open-label, randomized, paired design, multicenter study of the Cardiovascular
Autonomic Nervous Function Multi-Parameter Evaluation System (R6000) for evaluating
cardiovascular autonomic neuropathy. R6000 is novel intellectual diagnostic device for
cardiovascular autonomic reflex tests and heart rate variability analysis. A total of 85
subjects will be enrolled in trial Ⅰ and 150 subjects will be enrolled in trial Ⅱ. In trial
Ⅰ, subjects will be randomized to two groups, one of which will receive test by the tested
device first and the other one will be tested by conventional blood pressure kit. The primary
objective of this clinical trial is to evaluate the effectiveness of the Cardiovascular
Autonomic Nervous Function Multi-Parameter Evaluation System. The secondary objective is to
evaluate the safety of the cardiovascular autonomic testing system and stability.
Description:
Trial I Tested device: Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation
System (R6000). Control: Conventional blood pressure kit. Goal: To assess the consistency
between the tested device and the conventional method in measuring blood pressure.
Trial IIa Tested device: Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation
System (R6000). Control: Ambulatory holter station. Goal: To assess the consistency between
the tested device and the conventional devices in measuring heart rate variability (HRV).
Trial IIb Tested device: Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation
System (R6000). Control: Manual method with digital ECG machine, stethoscope and
sphygmomanometer. Goal: To assess the consistency between the tested device and the manual
method in determining cardiovascular autonomic neuropathy (CAN).