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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024843
Receipt No. R000028585
Scientific Title Study of BP Variability and Reactivity measured by new ICT-based BP monitoring system to anticipate future CV events
Date of disclosure of the study information 2016/11/15
Last modified on 2019/04/15

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Basic information
Public title Study of BP Variability and Reactivity measured by new ICT-based BP monitoring system to anticipate future CV events
Acronym Study of BP Variability and Reactivity measured by new ICT-based BP monitoring system to anticipate future CV events (ANTICIPATE)
Scientific Title Study of BP Variability and Reactivity measured by new ICT-based BP monitoring system to anticipate future CV events
Scientific Title:Acronym Study of BP Variability and Reactivity measured by new ICT-based BP monitoring system to anticipate future CV events (ANTICIPATE)
Region
Japan

Condition
Condition Patient with at least one of the following cardiovascular risk factor:
1. Diabetes mellitus
2. Dyslipidemia
3. Hypertension
4. Current smoking
5. Renal disease (eGFR <= 60 or positive proteinuria)
6. Atrial fibrillation
7. Metabolic syndrome
8. Chronic obstructive pulmonary disease
9. Sleep apnea syndrome
10. Age>=75
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to clarify the relationship between the individual risk of CV events and blood pressure variability taking into account individual facts in environment (temperature and atmospheric pressure) and lifestyle (activity and salt intake).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Onset of Major cardiovascular events*
*Major cardiovascular events; total death, cardiovascular death, sudden death, ischaemic heart disease (acute myocardial infarction, angina pectoris), cerebrovascular disease (cerebral infarction, cerebral embolism, cerebral hemorrhage, subarachnoid hemorrhage), and hospitalization by heart failure
Key secondary outcomes New onset of occlusive arteriosclerosis, aortic dissection, diabetes mellitus, chronic dialysis, atrial fibrillation, and hypertension.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient with at least one of the following cardiovascular risk factor:
1. Diabetes mellitus
2. Dyslipidemia
3. Hypertension
4. Current smoking
5. Renal disease (eGFR <= 60 or positive proteinuria)
6. Atrial fibrillation
7. Metabolic syndrome
8. Chronic obstructive pulmonary disease
9. Sleep apnea syndrome
10. Age>=75
Key exclusion criteria 1. Patients who have history of ischemic heart disease, erebrovascular disease (exclude asymptomatic and transient), occlusive arteriosclerosis, aortic dissection, and hospitalization for heart failure within 6 months before consent.
2. Patients with chronic renal failure in haemodialysis
3. Other seriously ill patients (e.g. end stage of cancer, active connective tissue disease)
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuomi Kario
Organization Jichi Medical University of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, Japan
TEL 0285-58-7538
Email kkario@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuomi Kario
Organization Jichi Medical University of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, Japan
TEL 0285-58-7538
Homepage URL
Email kkario@jichi.ac.jp

Sponsor
Institute Jichi Medical University of Medicine
Institute
Department

Funding Source
Organization Impulsing Paradigm Change through Disruptive Technologies Program (ImPACT)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 自治医科大学附属病院(栃木県)、南三陸病院(宮城県)、東吾妻診療所(群馬県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 07 Month 20 Day
Date of IRB
2016 Year 07 Month 20 Day
Anticipated trial start date
2016 Year 08 Month 22 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The investigators will collect the following information from August 2016 through March 2019:
1)blood pressure
2)environment (temperature and atmospheric pressure)
3)lifestyle (activity and salt intake)

Management information
Registered date
2016 Year 11 Month 15 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028585

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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