UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037436
Receipt number 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 2023/02/11 12:49:45

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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 or person

Institute

Nara Medical University

Institute

Department

Personal name



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

none

Publication of results

Unpublished


Result

URL related to results and publications

https://www.ejves.com/article/S1078-5884(20)30531-1/fulltext

Number of participants that the trial has enrolled

120

Results

In total, 118 patients were evaluated. The prevalence of Doppler ABI 0.90 was 45.8%. Taking the Dop-ABI as the reference, the sensitivity, specificity, accuracy, positive and negative predictive values of oscillometric ABI during the first measurement by the first observer were 89.1%, 94.4%, 94.1%, 91.8%, and 92.4%, respectively.

Results date posted

2021 Year 01 Month 20 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Age 73.0
Female 30
Height cm 164
Weight kg 68.5
Body mass index kg/m2 25.1
Smoking history 54
Coronary artery disease 31
Cerebrovascular disease 17
Hypertension 82
Dyslipidaemia 71
Diabetes 60
Chronic kidney disease 6

Participant flow

Patients suspected of LEAD because of intermittent claudication or more atypical pain when walking
Asymptomatic individuals with > 2 cardiovascular risk factors of the following.
Men >60 y or women >65 y
Regular cigarette smoking, treated type 2 DM > 5 y or
type 1 DM >20 y, treated hypertension or SBP > 140 mmHg
High blood cholesterol or treated by statins or
other lipid lowering agents
Documented history of CAD
Documented history of ischaemic stroke
Patients revascularised for LEAD

Adverse events

none

Outcome measures

Assessment of the diagnostic capacities of Osc ABI to detect a low Dop-ABI were determined as appropriate.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

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

2018 Year 12 Month 31 Day

Date trial data considered complete

2018 Year 12 Month 31 Day

Date analysis concluded

2018 Year 12 Month 31 Day


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

2023 Year 02 Month 11 Day



Link to view the page

Value
https://center6.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