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

NCT06447896 | Completed

• 1 other identifier: CARTS20210908
• Study Type: interventional
• Target: 235
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiovascular Autonomic Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The accuracy of the tested device versus conventional blood pressure kit with Korotkoff auscultatory technique for measuring blood pressure.

  up to 6 months

• The accuracy of the tested device versus the control device for measuring HRV.

  up to 6 months

Study Arms (2)

Arm A

EXPERIMENTAL

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)

Arm B

ACTIVE COMPARATOR

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; Device: Ambulatory holter station Model i12 plus

Interventions

Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (Model: R6000) DEVICE

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.

Arm A

Conventional method of CARTs DIAGNOSTIC_TEST

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.

Arm B

Ambulatory holter station Model i12 plus DEVICE

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.

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 or over, regardless of gender
• Voluntary membership to participate in the study and signing the Informed Consent Form.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 7, 2024
• Study Start: March 11, 2011
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share