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
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
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
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
