Evaluating the relationship between the radial pulse wave and gynecological disease
| ISRCTN | ISRCTN20480882 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20480882 |
| Secondary identifying numbers | TCHIRB-10703121-E |
- Submission date
- 19/05/2020
- Registration date
- 25/05/2020
- Last edited
- 24/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Harmonic analysis has been proven to be used to assess circulation status. In this study, we will observe the correlation between various common gynecological diseases and harmonic indicators through harmonic analysis. It is expected that harmonic indicators may become risk indicators for common gynecological diseases.
Who can participate?
Adults aged 20 and older with gynecological diseases.
What does the study involve?
Participants are provided with information sheets and obtain written informed consent. Information on lifestyle questionnaires and medical history are updated in each follow-up visit. Participants are then invited to a clinic room for radial pressure wave measurement.
What are the possible benefits and risks of participating?
Doctors take the radial pulse spectrum as risk variables based on the study and previous research. The patients may benefit from early detection of gynecological diseases in the future. The radial pulse measuring device is non-invasive.
Where is the study run from?
Taipei City Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
April 2018 to March 2022
Who is funding the study?
Taipei City Hospital (Taiwan)
Who is the main contact?
1. Dr Chih-Yu Chen (Public), tpech.anthony@m2k.com.tw
2. Dr Sheng-Hung Wang (Scientific), rax.wang@miiann.com
Contact information
Public
No.10, Sec. 4
Ren’ai Rd.
Da’an Dist
Taipei City
106
Taiwan
| Phone | +886 227093600 |
|---|---|
| tpech.anthony@m2k.com.tw |
Scientific
26F-1
No. 161
Songde Rd.
Taipei
11085
Taiwan
| Phone | +886 223463003 |
|---|---|
| rax.wang@miiann.com |
Study information
| Study design | Non-invasive observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | No participant information sheet available |
| Scientific title | A study on gynecological disease classification by harmonic analysis of pressure pulse waveform |
| Study objectives | Harmonic analysis has been proven to be used to assess circulation status. In this study, we will observe the correlation between various common gynecological diseases and harmonic indicators through harmonic analysis. It is expected that harmonic indicators may become risk indicators for common gynecological diseases. |
| Ethics approval(s) | Approved 20/04/2018, Institutional Review Board of Taipei City Hospital (8F., No. 10, Sec. 4, Ren’ai Rd., Da’an Dist., Taipei City 106, Taiwan (R.O.C.); +886 227093600; no email provided), ref: TCHIRB-10703121-E. Extension granted 08/04/2019. |
| Health condition(s) or problem(s) studied | Risk factors in gynecological diseases |
| Intervention | All subjects underwent radial pressure wave measurement. Spectrum analysis of radial pressure wave was calculated and transformed into Fourier series coefficients Cn and Pn. The enrolled group is investigated from April 2018. Both oral and written information about the study is given to the subjects. Informed consent is obtained from subjects after receiving approval from the institutional review board of Taipei City Hospital. The enrolled patients receive radial pulse wave measurement while referral until the end of the study or quit the project. The study consists of two clinical tests: 1. The cross-sectional part measures the radial blood pressure wave when a person first joined this study. The radial pulse spectrum index is derived from the measurement. The measurement is noninvasive. The interactions among the various common gynecological diseases and the risk factors (including the radial pulse spectrum index) are evaluated. The medical records of subjects including the blood test, urine examination, medication history, and lifestyle questionnaires to investigate the risk confounded such as age, gender, body mass index, blood pressure, low-density cholesterol, high-density cholesterol, and smoke history are analysed. 2. The longitudinal part: This part takes the risk evaluation of cross-sectional cohort study as the baseline. We continue to measure the radial pulse spectrum and record the new-onset gynecological diseases at 4-year intervals. In both parts of the cross-sectional and longitudinal part, it builds up the clinical risk variables for patients with gynecological diseases. Those clinical variables are safe enough to facilitate in routine clinical practice and also are cost-effective to repeat within months. Thus, periodic screening for those risk factors may help the doctors to evaluate the conditions of patients with gynecological diseases. |
| Intervention type | Other |
| Primary outcome measure | 1. Radial blood pressure wave is assessed using a miniature pressure transducer (TD01C, Taiwan) at time of enrollment 2. Hormones (such as E2, LH, FSH and Prolactin) are assessed using blood test at time of enrollment 3. CA-125 and AFP are assessed using blood test at time of enrollment |
| Secondary outcome measures | Physician diagnosis from the medical record at time of enrollment. |
| Overall study start date | 01/04/2018 |
| Completion date | 31/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1,500 |
| Total final enrolment | 825 |
| Key inclusion criteria | 1. Patients with gynecological diseases 2. Over 20 years old |
| Key exclusion criteria | Severe diseases or acute symptoms are excluded if the pressure wave measurement could not be performed |
| Date of first enrolment | 08/05/2018 |
| Date of final enrolment | 31/03/2022 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Renai Branch
Taipei
106
Taiwan
Sponsor information
Hospital/treatment centre
No.10, Sec. 4
Ren’ai Rd.
Da’an Dist.
Taipei City
106
Taiwan
| Phone | +886 227093600 |
|---|---|
| tpech.anthony@m2k.com.tw | |
| Website | http://english.tch.gov.taipei/ |
"ROR" |
https://ror.org/02gzfb532 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 16/10/2019 | 13/09/2022 | No | No | |
| Abstract results | 16/10/2019 | 13/09/2022 | No | No | |
| Abstract results | 16/10/2019 | 13/09/2022 | No | No | |
| Abstract results | 11/11/2019 | 13/09/2022 | No | No | |
| Results article | 01/09/2021 | 13/09/2022 | Yes | No | |
| Results article | 29/10/2021 | 13/09/2022 | Yes | No | |
| Protocol file | 14/09/2022 | No | No | ||
| Dataset | 24/06/2024 | No | No |
Additional files
Editorial Notes
24/06/2024: Link to dataset added.
14/09/2022: Uploaded protocol (not peer reviewed). Total final enrolment added.
13/09/2022: Publication references added.
22/05/2020: Trial’s existence confirmed by Institutional Review Board of Taipei City Hospital.
