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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026484
Receipt No. R000030421
Scientific Title Feasibility of enclosed zone oscillatory technique for the estimation of central venous pressure in patients with cardiovascular disease
Date of disclosure of the study information 2017/03/10
Last modified on 2019/09/11

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Basic information
Public title Feasibility of enclosed zone oscillatory technique for the estimation of central venous pressure in patients with cardiovascular disease
Acronym ezCVP
Scientific Title Feasibility of enclosed zone oscillatory technique for the estimation of central venous pressure in patients with cardiovascular disease
Scientific Title:Acronym Feasibility of enclosed zone oscillatory technique for the estimation of central venous pressure in patients with cardiovascular disease
Region
Japan

Condition
Condition Cardiovascular disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test the feasibility of novel non-invasive technique designated as ezCVP to estimate the central venous pressure in patient with heart failure and other cardiovascular diseases.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The relationship between estimated CVP measured by non-invasive technique and CVP measured by invasive technique
Key secondary outcomes Safety of CVP measured by non-invasive technique

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Measurement of ezCVP is performed at the end of right heart catheterization.
The investigator wraps the blood pressure cuff around patient`s upper arm and starts the measurement of cuff pressure by using automated sphygmomanometer equipped with the algorithm suitable for venous pressure measurement.
The cuff pressure is kept at 50 mm Hg for 30 seconds to measure the respiratory change of venous pressure.
Then, cuff pressure is gradually reduced by 5 mm Hg every 6 seconds from 50 mm Hg to 5 mm Hg.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient over 20 years old when informed consent is obtained.
Patients who are planned for right heart catheterization because of clinical reason.
Patient who can provide written informed consent
Key exclusion criteria Patient who can not put cuffs on both side upper arm by scheduled procedures or physical reasons.

Patient who judged inappropriate for conducting the study by the researcher or research sharing person
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yukihito
Middle name
Last name Higashi
Organization Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name Department of Cardiovascular Regeneration and Medicine
Zip code 734-8553
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL 082-257-5555
Email yhigashi@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Takayuki
Middle name
Last name Hidaka
Organization Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan
Division name Department of cardiovascular medicine
Zip code 734-8553
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL 082-257-5540
Homepage URL
Email hida-taka@umin.ac.jp

Sponsor
Institute Research Institute for Radiation Biology and Medicine, Hiroshima University
Department of Cardiovascular Regeneration and Medicine
Institute
Department

Funding Source
Organization NIHON KOHDEN CORPORATION
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Center for integrated medical research
Address 1-2-3 kasumi, minamiku, Hiroshima
Tel 082-257-5596
Email hugcp@hiroshima-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 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 10 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000030421
Publication of results Partially published

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000030421
Number of participants that the trial has enrolled 97
Results
ezCVP was significantly correlated with CVP . ezCVP had an underestimation bias of -2.5 mm Hg with 95% limits of agreement of -14.1 mmHg and 9.6 mm Hg for CVP . The AUCof ROC with ezCVP to detect the CVP >=12 cm H2O and CVP >10 mm Hg were 0.81 or 0.88, respectively. The sensitivity, specificity and positive likelihood ratio of ezCVP for the CVP >=8.8 mm Hg and CVP > 10 mm Hg were 0.59, 0.96 and 14.8 with a cut-off value of 11.9 and 0.79, 0.97 and 26.3 with a cut-off value of 12.7. 
Results date posted
2019 Year 09 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with coronary artery disease (n=9), valvular heart disease (n=54), cardiomyopathy (n=30) and other diseases (n=4). 
Participant flow
We included 97 patients who were older than 20 years of age and underwent right-heart catheterization at Hiroshima University Hospital from April 2017 to December 2017. 
Adverse events
none
Outcome measures
the feasibility of ezCVP measurement and the relationship between ezCVP and CVP measured by a catheter. 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 10 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 01 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 03 Month 09 Day
Last modified on
2019 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030421

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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