UMIN ID: UMIN000054063
Registered date:04/04/2024
Comparison Test of Cuffless Blood Pressure Monitor and ABPM for 25-Hour Monitoring
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | none |
| Date of first enrollment | 2024/02/01 |
| Target sample size | 10 |
| Countries of recruitment | Japan |
| Study type | Others,meta-analysis etc |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Differences between between ABPM and blood pressure measured by the device under study |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 35years-old |
|---|---|
| Age maximum | 69years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Those with evidence of chronic arrhythmia. 2. Who have uneven skin or dark skin such as black spots on the wrists due to wounds, burns, etc. 3. Who have a limb defect or a shunt in the left upper limb. 4. Who have difficulty in wearing the wearable device used in this evaluation test. (Minimum forearm circumference is less than 130 mm or more than 195 mm) 5. Those whose upper arm does not fit the cuff size for ABPM. (Those whose upper arm circumference is 200 mm or less or whose upper arm circumference is 420 mm or more) |
Related Information
| Primary Sponsor | TOKYO CENTER CLINIC |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Arblet Inc. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shota Nagahisa |
| Address | Yaesu KT Building 2F, 1-1-8, Yaesu, Chuo-ku, Tokyo Japan 1030028 |
| Telephone | 0332766935 |
| nagahisa_shota@tc-clinic.jp | |
| Affiliation | TOKYO CENTER CLINIC Clinical Research Group |
| scientific contact | |
| Name | Aki Tsuji |
| Address | Yaesu KT Building 2F, 1-1-8, Yaesu, Chuo-ku, Tokyo Japan |
| Telephone | 0332766935 |
| tccv@tc-clinic.jp | |
| Affiliation | TOKYO CENTER CLINIC Clinical Research Group |