Clinical trial NCT06447896: Clinical Validation of a Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Autonomic Neuropathy
Lead sponsor: REEM (Shenzhen) Healthcare Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-06-07
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The diagnostic accuracy of the tested device versus manual method for the diagnosis of cardiovascular autonomic neuropathy (CAN).
timeFrame: up to 6 months
Secondary outcomes:
measure: The accuracy of the tested device versus conventional blood pressure kit with Korotkoff auscultatory technique for measuring blood pressure.
timeFrame: up to 6 months
measure: The accuracy of the tested device versus the control device for measuring HRV.
timeFrame: up to 6 months
Other outcomes:
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