UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045159 |
|---|---|
| Receipt number | R000051589 |
| Scientific Title | Estimation of Clinical Features and Outcomes of Effusive Constrictive Pericarditis in Patients Presented with Cardiac Tamponade |
| Date of disclosure of the study information | 2021/08/15 |
| Last modified on | 2021/12/18 12:27:52 |
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Basic information
Public title
Estimation of Clinical Features and Outcomes of Effusive Constrictive Pericarditis in Patients Presented with Cardiac Tamponade
Acronym
ELUCIDATE-ECP
Scientific Title
Estimation of Clinical Features and Outcomes of Effusive Constrictive Pericarditis in Patients Presented with Cardiac Tamponade
Scientific Title:Acronym
ELUCIDATE-ECP
Region
| Japan |
Condition
Condition
Effusive constrictive pericarditis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence rate and prognosis of effusive constrictive pericarditis (ECP) in patients with pericardial effusion. In addition, we aimed to identify optical diagnostic method of ECP.
Basic objectives2
Others
Basic objectives -Others
To evaluate the incidence rate and prognosis of effusive constrictive pericarditis (ECP) in patients with pericardial effusion. In addition, we aimed to identify optical diagnostic method of ECP.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of effusive constrictive pericarditis
Key secondary outcomes
1)recurrence of pericardial effusion
2)surgical pericardial removal
3)1-year all-cause mortality, 1-year cardiovascular death, 1-year heart failure hospitalization, and cardiovascular event during one year
4)composite outcomes 1-year all-cause mortality and heart failure hospitalization
5)cardiac biomarker changes (BNP, NT-proBNP, and troponin)
6)renal function changes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergo (1) pericardiocentesis for pericardial effusion and (2) right heart catheterization to evaluate pre- and post-pericardiocentesis hemodynamics.
Key exclusion criteria
Patients who refused with participation in this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Matsumoto |
Organization
Toho University Facalty of Medicine
Division name
Department of Cardiology
Zip code
1438541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
shingomatsumoto0606@gmail.com
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Fujimoto |
Organization
Awaji medical center
Division name
Cardiology
Zip code
6560021
Address
137-1-1 Shioya, Sumoto
TEL
+81799221200
Homepage URL
watarutaru_328@yahoo.co.jp
Sponsor or person
Institute
Awaji medical center
Institute
Department
Personal name
Funding Source
Organization
None
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
Awaji medical center
Address
1-1-137 Shioya, Sumoto
Tel
+81799221200
Miki_Tsukahara@pref.hyogo.lg.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
淡路医療センター（兵庫県）、東邦大学医療センター大森病院（東京都）、岩手医科大学附属病院（岩手県）、群馬大学医学部附属病院（群馬県）、手稲渓仁会病院（北海道）、弘前大学大学院（青森県）、聖隷浜松病院（静岡県）、久留米大学病院（福岡県）、JCHO九州病院（福岡県）、一宮市立市民病院（愛知県）、姫路循環器病センター（兵庫県）、北里大学病院（東京都）、東海大学付属病院（神奈川県）、東京女子医科大学東医療センター（東京都）、虎ノ門病院（東京都）、獨協医科大学（栃木県）、大阪市立大学（大阪府）、帝京大学（東京都）、大阪医科薬科大学（大阪府）、京都桂病院（京都府）、大阪急性期・総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Right heart catheterization, echocardiography, and so on before and after pericardiocentesis
Management information
Registered date
| 2021 | Year | 08 | Month | 15 | Day |
Last modified on
| 2021 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051589
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