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

REEM (Shenzhen) Healthcare Co., Ltd

Status: Completed

Conditions: Cardiovascular Autonomic Neuropathy

Treatments: Diagnostic Test: Conventional method of CARTs; Device: Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (Model: R6000); Device: Ambulatory holter station Model i12 plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT06447896

CARTS20210908

Details and patient eligibility

About

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.

Full 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).

Enrollment: 235 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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235 participants in 2 patient groups

Arm A

Experimental group

Description:

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.

Treatment:

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

Arm B

Active Comparator group

Description:

In the active comparator arm, conventional method of CARTs and HRV analysis using a commercially available ambulatory holter station are conducted as control.

Treatment:

Device: Ambulatory holter station Model i12 plus

Diagnostic Test: Conventional method of CARTs