Evaluation of the utility of cardio-pulse wave examination device

Phase 1

• Conditions: Cerebral and cervical arteriosclerosis, ischemic heart disease, obstructive atherosclerosis,diabetes

• Registration Number: JPRN-jRCTs032180046
• Lead Sponsor: Matsumura Akira

Brief Summary

o adverse events related to the device were observed, and this study protocol was safe to perform. We believe that the research data and know-how obtained in this study will be useful for the development and improvement of cardio-pulse wave examination device. In addition, it is useful data for selecting patients who are effective in using this device, how to use them, and interpreting the results.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-29
• Study Completion: 2019-03-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients satisfying all of the following criteria are subject to this clinical trial.
1. Patients with arteriosclerotic diseases of cerebral artery / carotid arteriosclerosis, coronary arteriosclerosis, and arteriosclerosis obliterans.
2. Patients clinically diagnosed with arteriosclerosis by image inspection such as blood pressure, blood test, echo, CT, MRI, etc., or patients suspected.
3. Patient who can consent document by himself / herself. If writing is difficult due to hemiplegia or the like, put a substitute writer. If consent by the person himself / herself is difficult due to aphasia or the like, put a substitute person.
4. Patient who is over 20 years of age at consent acquisition.

Exclusion Criteria

Patients who conflict with one of the following criteria are excluded and not subject to this clinical study.
1. Patients who cannot wear device due to amputation of both lower leg.
2. Patients using active implantable medical devices such as cardiac pacemakers.
3. Patients who judged that medical doctor is inappropriate for participation in this study.
4. Patients with severe consciousness disturbance.
5. Diseases and postoperative patients who may have an adverse effect on the evaluation of this device such as circulatory insufficiency such as shock, chronic atrial fibrillation, vasculitis, artificial blood vessel replacement surgery, stent graft interpolation, etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified