Clinical Validation of a Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System

Cardiovascular Autonomic Neuropathy Clinical Trial

— CARTS  

Official title:

A Open-label, Randomised, Paired Design, Multicenter Study of a Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System With Intelligent Human-Machine Interaction for Assessing Cardiovascular Autonomic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06447896
• Other study ID #: CARTS20210908
• Status: Completed
• Phase: N/A
• 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
• 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: August 12, 2022
• Est. primary completion date: August 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals aged 18 or over, regardless of gender

• Voluntary membership to participate in the study and signing the Informed Consent Form.

Exclusion Criteria:

• For part I:

• Unable to cooperate with the examination.

• For part II:

• Ophthalmic examination within the past 1 month showed proliferative retinopathy, retinal detachment, fundus hemorrhage or presence of known history of illness described above;

• Known history of glaucoma or ophthalmic examination within the past 1 month suggests glaucoma;

• Poor control of hypertension (sedentary systolic blood pressure = 160mmHg or diastolic blood pressure =100mmHg);

• Known history of arrhythmia (except occasional premature beats), history of acute coronary syndrome within three months before signing the informed consent form;

• In a state of stress such as infection and surgery; Be in the acute or unstable phase of any disease;

• Pregnant women;

• Unable to cooperate with the examination.

Related Conditions & MeSH terms

• Cardiovascular Autonomic Neuropathy
• Nervous System Diseases

Intervention

Device:
• Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (Model: R6000)
Cardiovascular autonomic reflex tests (CARTs) and heart rate variability analysis (HRV) are conducted with Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (Model: R6000). CARTs include five standardized tests, which are heart rate response to lying-to-standing, Valsalva maneuver, deep breathing, and blood pressure response to lying-to-standing and sustained isometric handgrip. These series of movements act as "standardized stimuli" to trigger hemodynamic changes in the body, altering vagal and sympathetic activity through mechanisms such as the baroreflex, thereby producing changes in heart rate and blood pressure. The sensor-monitoring interactive design of the device ensures the standardization of these maneuvers.

Diagnostic Test:
• Conventional method of CARTs
Conventional method are conduced using blood pressure kit with manual sphygmomanometer and ECG machine. Conventional method and the investigated device are used simultaneously to record electrocardiograms. Conventional blood pressure taking are carried out in sequence with the investigated device. CARTs results from the conventional method are used as control.

Device:
• Ambulatory holter station Model i12 plus
Model i12 plus (manufactured by RENCARE) is an ambulatory holter station, which was approved by the Center for Medical Device Evaluation (CMDE), China National Medical Products Association (NMPA). It can analyze electrocardiogram and generate HRV indices, which include SDNN, RMSSD, NN50, pNN50, triangular index, average RR, deceleration capacity (DC), deceleration runs (DRs), VLF, LF, HF, LF/HF, and total power. Model i12 plus is used to analyzed the same ECG signals as the investigated device.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
REEM (Shenzhen) Healthcare Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic accuracy of the tested device versus manual method for the diagnosis of cardiovascular autonomic neuropathy (CAN).	Cohen's kappa coefficient will be used to assess the consistency between the tested device and the manual method in determining CAN status (positive or negative). The assessment will be conducted in part IIb.	up to 6 months
Secondary	The accuracy of the tested device versus conventional blood pressure kit with Korotkoff auscultatory technique for measuring blood pressure.	In part I, secondary outcome measures include the average difference and standard deviation of systolic and diastolic blood pressure values obtained using the tested device and the conventional blood pressure kit with Korotkoff auscultatory technique.	up to 6 months
Secondary	The accuracy of the tested device versus the control device for measuring HRV.	In part IIa, secondary outcome measures involve a comparative analysis of HRV indices obtained using the tested device and the control device.	up to 6 months