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

Not Applicable

Completed

• Conditions: Cardiovascular Autonomic Neuropathy

• Registration Number: NCT06447896
• Lead Sponsor: REEM (Shenzhen) Healthcare Co., Ltd

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.

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 Timeline

• Study Start: 2011-03-11
• Primary Completion: 2022-08-12
• Study Completion: 2022-08-12
• Study First Submitted: 2024-05-28
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-03
• Study First Posted: 2024-06-07
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
The diagnostic accuracy of the tested device versus manual method for the diagnosis of cardiovascular autonomic neuropathy (CAN).	up to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
The accuracy of the tested device versus conventional blood pressure kit with Korotkoff auscultatory technique for measuring blood pressure.	up to 6 months	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.
The accuracy of the tested device versus the control device for measuring HRV.	up to 6 months	In part IIa, secondary outcome measures involve a comparative analysis of HRV indices obtained using the tested device and the control device.