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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ChiCTR
Last refreshed on:	18 April 2017
Main ID:	ChiCTR-DCD-15006256
Date of registration:	2015-02-27
Prospective Registration:	Yes
Primary sponsor:	Fourth Military Medical University
Public title:	Validation of the Microlife BP A200 IMT and BP3GK1-4E automated blood pressure monitors
Scientific title:	Validation of the Microlife BP A200 IMT and BP3GK1-4E automated blood pressure monitors according to the European Society of Hypertension and the ANSI/AAMI/ISO protocols
Date of first enrolment:	2015-04-15
Target sample size:	Target condition:0;Difficult condition:0
Recruitment status:	Recruiting
URL:	http://www.chictr.org.cn/showproj.aspx?proj=10478
Study type:	Diagnostic test
Study design:	Diagnostic test for accuracy
Phase:	Diagnostic New Technique Clincal Study

Countries of recruitment
China

Contacts

Name:	Yi Wan
Address:	No.169, West Changle Road, XIncheng District, Xi'an, Shaanxi Province, China
Telephone:	+86 29 84774853
Email:	wanyi@fmmu.edu.cn
Affiliation:	Fourth Military Medical University

Name:	Yi Wan
Address:	No.169, West Changle Road, XIncheng District, Xi'an, Shaanxi Province, China
Telephone:	+86 29 84774853
Email:	wanyi@fmmu.edu.cn
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: Sex: balance between males and females;
Age range: All subjects should be at least 25 years of age;
Heart rhythm: Sinus rhythm unless the device is being validated for arrhythmias;
Blood pressure range: participants in each of the SBP and DBP recruitment ranges according to the protocols.
Exclusion criteria: Blood pressure ranges complete;
Poor quality sounds;
Range adjustment;
Arrhythmias;
Cuff size unavailable;
Observer disagreement;
Device failure; Distribution; and Others.

Age minimum: 25
Age maximum: 90
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Gold Standard:;Index test:;

Primary Outcome(s)

Blood pressure;

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Microlife Corporation

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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