Cardiovascular Autonomic NeuropathyCARTSNCT06447896

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

A study testing Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (Model: R6000), Conventional method of CARTs and Ambulatory holter station Model i12 plus in people with Cardiovascular Autonomic Neuropathy, run by REEM (Shenzhen) Healthcare Co., Ltd.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Cardiovascular Autonomic Neuropathy
What is being tested?: Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (Model: R6000), Conventional method of CARTs and Ambulatory holter station Model i12 plus
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 235 participants
Where: No sites listed yet
Study dates: 11 Mar 2011to 12 Aug 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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);

Show all 10Show fewer

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.

About this study

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

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.

Read the 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).

Conditions: Cardiovascular Autonomic Neuropathy
Being tested: Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (Model: R6000), Conventional method of CARTs, Ambulatory holter station Model i12 plus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
Conventional method of CARTsDiagnostic 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.
Ambulatory holter station Model i12 plusDevice
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.

Study groups in NCT06447896
Study group	Role	What they receive
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. Receives: 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. Receives: Diagnostic Test: Conventional method of CARTs; Device: Ambulatory holter station Model i12 plus

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
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.
Measured: 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.
Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Mar 201112 Aug 2022

First posted7 Jun 2024
Study start11 Mar 2011
Primary completion12 Aug 2022
Study completion12 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiovascular Autonomic NeuropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 235 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06447896
Sponsor's protocol ID: CARTS20210908
Acronym: CARTS
Status last verified: Jun 2024
First submitted: 28 May 2024
Last updated: 10 Jun 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Cardiovascular Autonomic Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06447896
Acronym / sponsor ID: CARTS / CARTS20210908
Conditions: Cardiovascular Autonomic Neuropathy
Study type: Interventional
Recruitment status: Completed
Enrolment: 235 participants (actual)
Lead sponsor: REEM (Shenzhen) Healthcare Co., LtdIndustry (pharma, biotech, devices)
Study start: 11 Mar 2011 (actual)
Primary completion: 12 Aug 2022 (actual)
Study completion: 12 Aug 2022 (actual)
First posted: 7 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A	Experimental	Device: Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (Model: R6000)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.
Arm B	Active comparator	Diagnostic Test: Conventional method of CARTs, Device: Ambulatory holter station Model i12 plusIn the active comparator arm, conventional method of CARTs and HRV analysis using a commercially available ambulatory holter station are conducted as control.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (10 listed)

For part I:
For part II:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Arm A
Conventional method of CARTsConventional 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.	Diagnostic test	Arm B
Ambulatory holter station Model i12 plusModel 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.	Device	Arm B

Primary outcome

The diagnostic accuracy of the tested device versus manual method for the diagnosis of cardiovascular autonomic neuropathy (CAN).
Time frame: 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.

2 secondary outcomes

The accuracy of the tested device versus conventional blood pressure kit with Korotkoff auscultatory technique for measuring blood pressure.
Time frame: up to 6 months
The accuracy of the tested device versus the control device for measuring HRV.
Time frame: up to 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
Individual participant dataSharing planned: No

Related trials for Cardiovascular Autonomic Neuropathy

RecruitingObservational study
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RecruitingPhase 2
24VA022; VATCH Alpelisib for TIE2/PIK3CA Pathway VAs
Vascular Anomalies, Vascular Anomaly
RecruitingPhase 2
A Study of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH) (ROCSTAR STUDY)
Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension, Interstitial Lung Disease
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The Effect of Autonomic Neuropathy Status on the Endpoint Events in Diabetes Patients With Coronary Heart Disease and Sleep Apnea.
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The diagnostic accuracy of the tested device versus manual method for the diagnosis of cardiovascular autonomic neuropathy (CAN). (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06447896.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.