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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037436
Receipt No. R000042560
Scientific Title Validation of Ankle-Barchial Index Measurement Using a Multi-Cuff Oscillometric Device Versus the Standard Doppler Method.
Date of disclosure of the study information 2019/08/01
Last modified on 2019/07/21

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Basic information
Public title Validation of Ankle-Barchial Index Measurement Using a Multi-Cuff Oscillometric Device Versus the Standard Doppler Method.
Acronym Validation of Ankle-Barchial Index Measurement Using a Multi-Cuff Oscillometric Device
Scientific Title Validation of Ankle-Barchial Index Measurement Using a Multi-Cuff Oscillometric Device Versus the Standard Doppler Method.
Scientific Title:Acronym Validation of Ankle-Barchial Index Measurement Using a Multi-Cuff Oscillometric Device
Region
Japan Europe

Condition
Condition Peripheral arterial disease
Classification by specialty
Cardiology Vascular surgery Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To validate the diagnostic ability and reproducibility of a 4-cuff automated dedicated oscillometric device (HBP-8000, OMRON HEALTHCARE) compared to the standard Doppler method in the vascular laboratory setting.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sensitivity, specificity, PPV, NPV, and Prevalence of the oscillometric method to detect a low (<0.90) ABI were determined by usual formula, taking the Doppler method as the reference.
Key secondary outcomes The intra and interobserver variability of measurements were first assessed by the determination of the intraclass correlation coefficient (ICC) of agreement for each method. In order to determine methods with the best reproducibility (the lowest variability), 95% CI of these ICCs were then compared. A second analysis of intra- and inter-observer reproducibility were made by the Bland and Altman's method.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients suspect for lower extremity artery disease (LEAD) because of intermittent claudication or more atypical pain when walking, critical limb ischemia or leg/foot ulcers
Asymptomatic individuals with the presence of at least two cardiovascular risk factors among the following
Men > 60 years or women > 65 years
Regular cigarette smoking (either current or in the past) for more than 10 years, Treated type-2 diabetes mellitus >5 years or type-1 diabetes mellitus >20 years, Treated hypertension or systolic blood pressure>140mmHg
High blood cholesterol (either total-C >240 mg/dl or LDL-C >160 mg/dl) or treated by statins or other lipid-lowering agents
Documented history of coronary artery disease (history of percutaneous coronary intervention or coronary artery bypass grafting or previous myocardial infarction, or coronary artery disease documented by coronary angiography)
Documented history of ischemic stroke
Patients with re-vascularized LEAD

Key exclusion criteria Cardiac arrhythmia: Atrial fibrillation, atrial flutter, frequent supra and ventricular ectopic beats
Patients under dialysis
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Shigeo
Middle name
Last name Ichihashi
Organization Nara Medical University
Division name Radiology
Zip code 634-8521
Address 840 Shijocho, Kashihara, Nara
TEL 0744-29-8900
Email ichihash@naramed-u.ac.jp

Public contact
Name of contact person
1st name Shigeo
Middle name
Last name Ichihashi
Organization Nara Medical University
Division name Radiology
Zip code 634-8521
Address 840 Shijocho, Kashihara, Nara
TEL 0744-29-8900
Homepage URL
Email ichihash@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Nara Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nara Medical University Clinical Research Center
Address 840 Shijocho, Kashihara, Nara
Tel 0744-29-8836
Email icats@naramed-u.ac.jp

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

Other administrative information
Date of disclosure of the study information
2019 Year 08 Month 01 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 120
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 No longer recruiting
Date of protocol fixation
2016 Year 02 Month 08 Day
Date of IRB
2016 Year 02 Month 08 Day
Anticipated trial start date
2016 Year 03 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Diagnostic accuracy of oscillometric ABI was excellent when compared to Doppler ABI

Management information
Registered date
2019 Year 07 Month 21 Day
Last modified on
2019 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042560

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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