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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Autonomic Neuropathy
• Intervention / Treatment: Diagnostic test: Conventional method of CARTs; Device: Ambulatory holter station Model i12 plus; Device: Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (Model: R6000)

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm B; In the active comparator arm, conventional method of CARTs and HRV analysis using a commercially available ambulatory holter station are conducted as control.	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.
Experimental: Arm A; In the experimental arm, the Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (Model: R6000, REEM (Shenzhen) Healthcare Co., Ltd) is used for both cardiovascular autonomic reflex tests (CARTs) and heart rate variability (HRV) analysis.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: REEM (Shenzhen) Healthcare Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2011
• Primary Completion (Actual): August 12, 2022
• Study Completion (Actual): August 12, 2022

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: CARTS20210908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No