Evaluation of the utility of cardio-pulse wave examination device

JRCT ID: jRCTs032180046

Registered date:29/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cerebral and cervical arteriosclerosis, ischemic heart disease, obstructive atherosclerosis,diabetes
• Date of first enrollment: 06/12/2018
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Measurement using by the atherosclerosis degree measuring device

Outcome(s)

• Primary Outcome: PWV (Pulse Wave Velocity)
• Secondary Outcome: ABI (Ankle brachial pressure index), CAVI (Cardio-ankle vascular index), arterial stenosis rate, arterial blood flow velocity, arterial intimal hyperplasia, blood pressure, HbA1c, LDL-cho, TG, HDL-cho, smoking index.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Matsumura Akira
• Source(s) of Monetary Support: Japan Science and Technology Agency