UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043132 |
|---|---|
| Receipt number | R000049232 |
| Scientific Title | Retrospective observational study of preload reserve in patients with atrial septal defect by noninvasive leg-positive pressure stress echocardiography |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2022/01/27 16:14:31 |
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Basic information
Public title
Retrospective observational study of preload reserve in patients with atrial septal defect by noninvasive leg-positive pressure stress echocardiography
Acronym
LPP-ASD
Scientific Title
Retrospective observational study of preload reserve in patients with atrial septal defect by noninvasive leg-positive pressure stress echocardiography
Scientific Title:Acronym
LPP-ASD
Region
| Japan |
Condition
Condition
atrial septal defect
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare how the response to leg-positive pressure stress differs between normal controls and patients with atrial septal defect.
Basic objectives2
Others
Basic objectives -Others
To clarify the hemodynamic characteristics of atrial septal defect by examining how the response to leg-positive pressure stress changes 6 months after atrial septal defect closure in patients with atrial septal defect.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is the difference in stroke volume between resting and stressed leg-positive pressure before closure (up to 3 days) between normal controls and patients with atrial septal defect.
Key secondary outcomes
Secondary outcomes: (1) Difference in stroke volume between rest and load before (within 3 days) and 6 months after atrial septal defect closure (2) Normal control and patients with atrial septal defect the difference between the stroke volume at rest and at load 6 months after atrial septal defect closure.
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with atrial septal defect is confirmed by imaging tests such as echocardiography, cardiac CT, or cardiac MRI, and is hemodynamically stable (NYHA I-III) among patients undergoing atrial septal defect closure at our hospital. Patients were selected.
Key exclusion criteria
1. Poor control patients with hypertension (160/90 mmHg) or hypotension (90/50 mmHg)
2. Those with a history of acute other organ diseases such as pulmonary embolus within 3 months
3. NYHA Patients with congestive heart failure with cardiac function IV degree
4. Patients with severe hepatorenal failure
5. Pregnant woman
6. Patients with or have a history of deep vein thrombosis
7. Patients with trauma or skin diseases in the leg-positive pressure area of the lower leg
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Suzuki |
| Middle name | |
| Last name | Makiko |
Organization
Kobe University Hospital
Division name
cardiovascular medicine
Zip code
650-0011
Address
Kusunokicho7-5-2Chuo-ku Kobe-shi
TEL
+819051530817
suzukimakko@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Makiko |
| Middle name | |
| Last name | Suzuki |
Organization
Kobe University Hospital
Division name
cardiovascular medicine
Zip code
650-0011
Address
Kusunokicho7-5-2 Chuo-ku Kobe-shi
TEL
+819051530817
Homepage URL
suzukimakko@yahoo.co.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Kobe University Hospital clinical and translational research center
Address
Kusunokicho7-5-2Chuo-ku Kobe-shi Hyogo Prefecture
Tel
0783826669
suzukimakko@yahoo.co.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
| 2021 | Year | 09 | 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
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
Terminated
Date of protocol fixation
| 2021 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2021 | Year | 01 | Month | 26 | Day |
Last modified on
| 2022 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049232
