Wrist ICT-Based Sleep and CircaDian BlOod Pressure Monitoring Program - Night blood pressure registry: [WISDOM-Night Registry]

UMIN ID: UMIN000043599

Registered date:15/03/2021

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: myocardial infarction, angina pectoris, heart failure, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, aortic dissection, peripheral arterial disease, hypertension, diabetes mellitus, hyperlipidemia, atrial fibrillation, chronic kidney disease, chronic obstructive pulmonary disease, sleep apnea syndrome, hyperuricemia
• Date of first enrollment: 2021/03/18
• Target sample size: 3500
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Relationship between the average of wrist-measured nighttimeblood pressure values and the onset of major cardiovascular events Major cardiovascular events: total death, cardiovascular death, sudden death, ischemic heart disease (acute myocardial infarction, angina pectoris), cerebrovascular disease (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage), aortic dissection, and hospitalization by heart failure, enhanced treatment of worsening heart failure symptoms
• Secondary Outcome: 1) Relationship between the average of wrist-measured nighttimeblood pressure values and the onset of the following diseases; New onset of atrial fibrillation, peripheral arterial disease, deterioration of renal function (including initiation of chronic dialysis), diabetes mellitus, or onset of gout attack 2) Relationship between the mean value of each wrist BP measurement point (2 o'clock, 3 o'clock, 4 o'clock, 4 hours after going to bed, morning, or evening) and the onset of cardiovascular disease 3) Relationship between the wrist BP changes (from baseline to 1-year-later) and the onset of cardiovascular event

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients who meet the following exclusion criteria: 1) Shift worker (those who are engaged in night shifts more than 3 days a week) 2) Patients who have history of cerebrovascular disease (exclude asymptomatic and transient) within 6 months before enrollment. 3) Patients with chronic renal failure on hemodialysis 4) Other serious diseases (cancer, collagen disease, etc.). However, patients who have been confirmed to be in remission or cure of cancer can be registered. 5) Patients using a pacemaker

Related Information

• Primary Sponsor: Jichi Medical University School of Medicine
• Secondary Sponsor: OMRON HEALTHCARE Co., Ltd.
• Source(s) of Monetary Support: Super Circulation Monitoring with High Technology R & D Center