UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000022722 |
| Receipt No. | R000025921 |
| Scientific Title | An analysis on validity of monitoring by wristwatch-type sphygmograph in detecting of atrial fibrillation |
| Date of disclosure of the study information | 2016/06/13 |
| Last modified on | 2020/06/17 (Ver. 5) |
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| Basic information | ||
| Public title | An analysis on validity of monitoring by wristwatch-type sphygmograph in detecting of atrial fibrillation | |
| Acronym | CVI ARO 3a study | |
| Scientific Title | An analysis on validity of monitoring by wristwatch-type sphygmograph in detecting of atrial fibrillation | |
| Scientific Title:Acronym | CVI ARO 3a study | |
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| Condition | ||
| Condition | Paroxysmal or chronic atrial fibrillation requiring 24h ambulatory monitoring | |
| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | To clarify the degree of coincidence of atrial fibrillation diagnosis between wristwatch-type sphygmograph and 24h ambulatory electrocardiogram |
| Basic objectives2 | Others |
| Basic objectives -Others | Validation of sphygmographic devise |
| Trial characteristics_1 | Exploratory |
| Trial characteristics_2 | Others |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | The degree of coincidence of atrial fibrillation diagnosis between wristwatch-type sphygmograph and 24h ambulatory electrocardiogram |
| Key secondary outcomes | None |
| Base | |
| Study type | Observational |
| Study design | |
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| Randomization | |
| Randomization unit | |
| Blinding | |
| Control | |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | |
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| Purpose of intervention | |
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| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | Paroxysmal or chronic atrial fibrillation requiring 24h ambulatory monitoring | |||
| Key exclusion criteria | Metallic allergy | |||
| Target sample size | 85 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | The Cardiovascular Institute | ||||||
| Division name | Director | ||||||
| Zip code | 106-0031 | ||||||
| Address | 3-2-19 Nishiazabu, Minato-Ku, Tokyo. ZIP: 106-0031 | ||||||
| TEL | +81-3-3408-2151 | ||||||
| yamt-tky@umin.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Cardiovascular Institute Academic Research Organization (CVI ARO) | ||||||
| Division name | Head office | ||||||
| Zip code | 106-0031 | ||||||
| Address | 3-2-19 Nishiazabu, Minato-Ku, Tokyo | ||||||
| TEL | +81-3-3408-2151 | ||||||
| Homepage URL | |||||||
| matsuda@cvi.or.jp | |||||||
| Sponsor | |
| Institute | The Cardiovascular Institute Academic Organization (CVI ARO) |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Seiko Epson Corporation |
| Organization | |
| Division | |
| Category of Funding Organization | Profit organization |
| Nationality of Funding Organization | Japan |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Ethical Committee of The Cardiovascular Institute |
| Address | Nishi-azabu 3-2-19, Minato-ku, Tokyo |
| Tel | 03-3408-2151 |
| matsuda@cvi.or.jp | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
| Study ID_2 | |
| Org. issuing International ID_2 | |
| IND to MHLW | |
| Institutions | |
| Institutions | 心臓血管研究所付属病院（The Cardiovascular Institute） |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | https://www.cvi.or.jp/kenkyujo/cviaro.html#link01 |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | https://www.cvi.or.jp/kenkyujo/cviaro.html#link01 | ||||||
| Number of participants that the trial has enrolled | 84 | ||||||
| Results | In patient-basis, AF was detected in 28 with Holter, 29 with pulse monitoring out of 84 patients. In time-interval-basis, AF was detected in 724 with Holter, 682 with pulse monitoring, out of 3660 time intervals. |
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| Baseline Characteristics | 73 paroxysmal AF and 11 chronic AF |
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| Participant flow | Outpatients were recruited |
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| Adverse events | None |
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| Outcome measures | Diagnosis of AF |
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| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Other | |
| Other related information | Recruitment and analysis were completed.
Accepted to "Japanese Journal of Electrocardiology" in Mar, 2020. |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025921 |
