UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048909 |
|---|---|
| Receipt number | R000055730 |
| Scientific Title | A comparison of the cardio-ankle vascular index in smokers with normal spirometry and smokers with airflow limitation: a cross-sectional study |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2022/09/12 11:23:34 |
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Basic information
Public title
The relationship between COPD and arteriosclerosis: a prospective study
Acronym
The relationship of arteriosclerosis and chronic obstructive pulmonary disease
Scientific Title
A comparison of the cardio-ankle vascular index in smokers with normal spirometry and smokers with airflow limitation: a cross-sectional study
Scientific Title:Acronym
A comparison of the cardio-ankle vascular index in smokers with normal spirometry and smokers with airflow limitation: a cross-sectional study
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Medicine in general | Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to elucidate the influence of the presence of COPD on systemic arteriosclerosis assessed by CAVI.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CAVI(cardio-ankle vascular index)
FEV1(forced expiratory volume in 1 second)
FVC(forced vital capacity, forced expiratory volume in 1 second)
FEV1/FVC
Key secondary outcomes
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The diagnosis of COPD is made according to the COPD Guidelines of the Japanese Respiratory Society, based on a history of smoking of 10 pack-years or more, evidence of irreversible airflow obstruction, and exclusion of other chronic respiratory diseases. Volunteers aged 60 years and older will be included if they have no abnormal respiratory function on spirometry and have no history of smoking (never smoker, NS) or if they have a history of smoking for more than 10 pack-years but no abnormal spirometry (current or past smoker, CS or PS).
Key exclusion criteria
The subjects with COPD exacerbations and/or respiratory infection within 2 months, severe cardiac arrhythmia, heart failure, and severe systemic diseases such as inability to perform spirometry and measurement of CAVI were excluded.
Target sample size
129
Research contact person
Name of lead principal investigator
| 1st name | Kawachi |
| Middle name | |
| Last name | Shohei |
Organization
Nagoya University
Division name
Department of Integrated Health Sciences Nagoya University Graduate School of Medicine
Zip code
461-0047
Address
1-1-20 Daiko-minami, Higashi-ku, Nagoya 461-8673
TEL
052-719-1365
kawachi@met.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kawachi |
| Middle name | |
| Last name | Shohei |
Organization
Nagoya University
Division name
Department of Integrated Health Sciences Nagoya University Graduate School of Medicine
Zip code
461-0047
Address
1-1-20 Daiko-minami, Higashi-ku, Nagoya 461-8673
TEL
052-719-1365
Homepage URL
kawachi@met.nagoya-u.ac.jp
Sponsor or person
Institute
Shinshu university
Institute
Department
Personal name
Funding Source
Organization
Shinshu university/self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu university of medical ethics committee
Address
mdrinri@shinshu-u.ac.jp
Tel
0263-37-2572
mdrinri@shinshu-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
| 2022 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.umin.ac.jp/ctr/index-j.htm
Publication of results
Unpublished
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/resp.14150_445
Number of participants that the trial has enrolled
190
Results
As a result, 83 never-smokers with Normal spirometry (NS), 53 current/past-smokers with NS, and 54 current/past-smokers with Airflow limitation (AL) were included in the analysis (p<0.01). CAVI was significantly higher in current/past-smokers with AL.
Results date posted
| 2022 | Year | 09 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 247 subjects were included in this study, including 92 subjects enrolled at Shinshu University Hospital, 21 subjects enrolled at Shinsei Hospital, 25 subjects enrolled at Iizuna Municipal Hospital, and 109 subjects enrolled at the health check-up event of Omi Village Office. Among 106 never-smokers, 23 subjects were excluded from the analysis because their spirometry results were below the LLN, and the remaining 83 subjects were classified as never-smokers with NS. In 75 current/past-smokers with FEV1/FVC > 70%, 22 subjects were excluded from the analysis because their spirometry results were below the LLN, and the remaining 53 were classified as current/past-smokers with NS. Among the 65 current/past-smokers with FEV1/FVC < 70%, 11 subjects who had FEV1/FVC > LLN were excluded from the analysis, and the remaining 54 subjects were classified as current/past-smokers with AL.
Thirty-four of 54 subjects were previously diagnosed with COPD and one subject was diagnosed with Combined pulmonary fibrosis and emphysema (CPFE) in the current/past-smokers with AL. The current/past-smokers with AL had significantly higher age, pack-years, and significantly lower BMI than the current/past-smokers with NS. Over half of the current/past-smokers with AL had mild to moderate severity of airflow limitation. Comorbidities checklist revealed that hypertension was the most frequent comorbidity in all groups, having 20-40% of subjects in each group. However, there was no significant difference in the rate of hypertension among the three groups. The ratio of subjects with hyperlipidemia was significantly higher in the never-smokers with NS in comparison to the current/past-smokers with AL (p<0.01). There were no significant differences in rates of the other comorbidities among the three groups.
Participant flow
The subjects were recruited at Shinshu University Hospital (Matsumoto, Nagano, Japan) from August 2017. After that, we started recruiting subjects at Shinsei Hospital (Obuse, Nagano, Japan) and Iizuna Municipal Hospital (Iizuna, Nagano, Japan) from December 2019 and September 2020 respectively to further increase the number of participants. In these hospitals, the outpatients over 60 years old had been treated as with COPD, as other diseases than COPD and their families were included in the study when they want to do health screening and consent for the present study was obtained from them.
Adverse events
not applicable
Outcome measures
comorbidities
Smoking status
FEV1
FVC
CAVI
ABI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The subjects were recruited at Shinshu University Hospital (Matsumoto, Nagano, Japan) from August 2017. After that, we started recruiting subjects at Shinsei Hospital (Obuse, Nagano, Japan) and Iizuna Municipal Hospital (Iizuna, Nagano, Japan) from December 2019 and September 2020 respectively to further increase the number of participants. In these hospitals, the outpatients over 60 years old had been treated as with COPD, as other diseases than COPD and their families were included in the study when they want to do health screening and consent for the present study was obtained from them.
Management information
Registered date
| 2022 | Year | 09 | Month | 12 | Day |
Last modified on
| 2022 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055730
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