Diagnostic Performance of Cardiovascular Autonomic NeuropathyNCT02459522
Bayesian Estimation of Diagnostic Performance for Cardiovascular Autonomic Neuropathy
An observational study of Diagnostic Performance of Cardiovascular Autonomic Neuropathy, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
Trial summary
This study aimed to evaluate the reference values for the short-term heart rate variable (HRV), estimate the performance of cardiovascular autonomic neuropathy (CAN) diagnostic tests in the absence of a gold standard, and assess CAN prevalence in our cross-sectional dataset. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Performance of Cardiovascular Autonomic Neuropathy
- What is being tested?
- not intervention
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Jun 2016
- Phase
- Observational
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with inclusion and exclusion criteria were recruited from healthy examination centres to assess cardiovascular autonomic function using both the short-term heart rate variability and Ewing's tests.
Who may be able to join
- Survey participants with undiagnosed CAN, aged 30-80 years, were included in this study.
Who cannot join
- Some subjects were excluded from the study to eliminate potential confounding factors that may have influenced their CA function 11. Briefly, the exclusion criteria were as follows:
- history or findings of arrhythmia, and hyperthyroidism or hypothyroidism;
- pregnancy or lactation; and/or
- serious hepatic or renal dysfunctions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bayesian Estimation of Diagnostic Performance of Short-term Heart Rate Variability for Cardiovascular Autonomic Neuropathy Without a Gold Standard
This study aimed to evaluate the reference values for the short-term heart rate variable (HRV), estimate the performance of cardiovascular autonomic neuropathy (CAN) diagnostic tests in the absence of a gold standard, and assess CAN prevalence in our cross-sectional dataset.
Read the detailed description
The CAN prevalence is rapidly growing in all populations worldwide. No document has been reported about normal reference values for CAN using this test in the Chinese population. This study aimed to evaluate the reference values for the short-term HRV in a large cross-sectional dataset, and to estimate sensitivities and specificities of CAN diagnostic tests using the Bayesian approach, in the absence of a gold standard in another independence dataset. Finally, CAN prevalence was estimated in the investigators' cross-sectional dataset. Firstly, the reference the values for the short-term HRV were calculated in the investigators' previous study (including 371 healthy subjects). This study dataset contained 88 subjects who completed both the short-term HRV test and Ewing's test. Simultaneous inferences about the population prevalence and the performance of each diagnostic test were possible using the Bayesian approach without a gold standard.
- Being tested
- not intervention
- Keywords
- Bayesian estimation, short-term heart rate variability, cardiovascular autonomic neuropathy, diagnostic performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not interventionOther
This is a cross-sectional study for estimation of diagnostic performance.
| Study group | Role | What they receive |
|---|---|---|
| Dr.Tang's research group | This group included participants with completed both the short-term HRV test and Ewing's test. Receives: Other: not intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular autonomic function evaluate by short-term heart rate variability test
Both short-term heart rate variability and Ewing's test measure cardiovascular autonomic function
Measured: participants will be measured for the duration of outpatient stay, an expected average of two days
Cardiovascular autonomic function evaluate by Ewing's test
Both short-term heart rate variability and Ewing's test measure cardiovascular autonomic function
Measured: participants will be measured for the duration of outpatient stay, an expected average of two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startJan 2011
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diagnostic Performance of 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital
- Responsible party
- Principal investigator, Zihui Tang, Huashan Hospital
- Investigators
- Zihui Tang, M.D and Ph.D, Principal investigator, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459522
- Sponsor's protocol ID
- CANHRVB_Dr.Tang
- Status last verified
- Sep 2016
- First submitted
- 27 May 2015
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zeng F, Tang ZH, Li Z, Yu X, Zhou L. Normative reference of short-term heart rate variability and estimation of cardiovascular autonomic neuropathy prevalence in Chinese people. J Endocrinol Invest. 2014 Apr;37(4):385-91. doi: 10.1007/s40618-013-0047-4. Epub 2014 Jan 9.
PubMed 24633734Tang ZH, Zeng F, Yu X, Zhou L. Bayesian estimation of cardiovascular autonomic neuropathy diagnostic test based on baroreflex sensitivity in the absence of a gold standard. Int J Cardiol. 2014 Feb 15;171(3):e78-80. doi: 10.1016/j.ijcard.2013.11.100. Epub 2013 Dec 6. No abstract available.
PubMed 24360155Tang ZH, Wang L, Zeng F, Li Z, Yu X, Zhang K, Zhou L. Bayesian estimation of cardiovascular autonomic neuropathy diagnostic test based on short-term heart rate variability without a gold standard. BMJ Open. 2014 Oct 6;4(9):e005096. doi: 10.1136/bmjopen-2014-005096.
PubMed 25287103Tang ZH, Zeng F, Ye K, Yu X, Zhou L. The analysis of a reference value for baroreflex sensitivity and cardiovascular autonomic neuropathy prevalence in a Chinese population. Eur J Med Res. 2014 Feb 12;19(1):8. doi: 10.1186/2047-783X-19-8.
PubMed 24521230
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bayesian Estimation of Diagnostic Performance of Short-term Heart Rate Variability for Cardiovascular Autonomic Neuropathy Without a Gold Standard
- ClinicalTrials.gov ID
- NCT02459522
- Acronym / sponsor ID
- CANHRVB_Dr.Tang
- Keywords
- Bayesian estimation, short-term heart rate variability, cardiovascular autonomic neuropathy, diagnostic performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Collaborators
- Huashan Hospital
- Study start
- Jan 2011
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Jun 2015 (estimated)
- 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.
This study aimed to evaluate the reference values for the short-term heart rate variable (HRV), estimate the performance of cardiovascular autonomic neuropathy (CAN) diagnostic tests in the absence of a gold standard, and assess CAN prevalence in our cross-sectional dataset.
Detailed description
The CAN prevalence is rapidly growing in all populations worldwide. No document has been reported about normal reference values for CAN using this test in the Chinese population. This study aimed to evaluate the reference values for the short-term HRV in a large cross-sectional dataset, and to estimate sensitivities and specificities of CAN diagnostic tests using the Bayesian approach, in the absence of a gold standard in another independence dataset. Finally, CAN prevalence was estimated in the investigators' cross-sectional dataset. Firstly, the reference the values for the short-term HRV were calculated in the investigators' previous study (including 371 healthy subjects). This study dataset contained 88 subjects who completed both the short-term HRV test and Ewing's test. Simultaneous inferences about the population prevalence and the performance of each diagnostic test were possible using the Bayesian approach without a gold standard.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dr.Tang's research group | – | Other: not interventionThis group included participants with completed both the short-term HRV test and Ewing's test. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with inclusion and exclusion criteria were recruited from healthy examination centres to assess cardiovascular autonomic function using both the short-term heart rate variability and Ewing's tests.
Key inclusion criteria (1 listed)
- Survey participants with undiagnosed CAN, aged 30-80 years, were included in this study.
Key exclusion criteria (4 listed)
- Some subjects were excluded from the study to eliminate potential confounding factors that may have influenced their CA function 11. Briefly, the exclusion criteria were as follows:
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 |
|---|---|---|
| not interventionThis is a cross-sectional study for estimation of diagnostic performance. | Other | Dr.Tang's research group |
Primary outcome
Cardiovascular autonomic function evaluate by short-term heart rate variability test
Time frame: participants will be measured for the duration of outpatient stay, an expected average of two days
Both short-term heart rate variability and Ewing's test measure cardiovascular autonomic function
Cardiovascular autonomic function evaluate by Ewing's test
Time frame: participants will be measured for the duration of outpatient stay, an expected average of two days
Both short-term heart rate variability and Ewing's test measure cardiovascular autonomic function
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 22 Sep 2016.
- Results publication: PubMed 24633734Zeng F, Tang ZH, Li Z, Yu X, Zhou L. Normative reference of short-term heart rate variability and estimation of cardiovascular autonomic neuropathy prevalence in Chinese people. J Endocrinol Invest. 2014 Apr;37(4):385-91. doi: 10.1007/s40618-013-0047-4. Epub 2014 Jan 9.
- Results publication: PubMed 24360155Tang ZH, Zeng F, Yu X, Zhou L. Bayesian estimation of cardiovascular autonomic neuropathy diagnostic test based on baroreflex sensitivity in the absence of a gold standard. Int J Cardiol. 2014 Feb 15;171(3):e78-80. doi: 10.1016/j.ijcard.2013.11.100. Epub 2013 Dec 6. No abstract available.
- Results publication: PubMed 25287103Tang ZH, Wang L, Zeng F, Li Z, Yu X, Zhang K, Zhou L. Bayesian estimation of cardiovascular autonomic neuropathy diagnostic test based on short-term heart rate variability without a gold standard. BMJ Open. 2014 Oct 6;4(9):e005096. doi: 10.1136/bmjopen-2014-005096.
- Results publication: PubMed 24521230Tang ZH, Zeng F, Ye K, Yu X, Zhou L. The analysis of a reference value for baroreflex sensitivity and cardiovascular autonomic neuropathy prevalence in a Chinese population. Eur J Med Res. 2014 Feb 12;19(1):8. doi: 10.1186/2047-783X-19-8.
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.
Zihui Tang, M.D and Ph.D principal investigator
Shanghai Tongji Hospital, Tongji University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic Performance of Cardiovascular Autonomic Neuropathy, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
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 1 inclusion and 4 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 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Cardiovascular autonomic function evaluate by short-term heart rate variability test (time frame: participants will be measured for the duration of outpatient stay, an expected average of two days). The study lists 2 primary outcomes in all. 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 NCT02459522, which also lists 4 linked publications.
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 22 Sep 2016.