UMIN-CTR Clinical Trial

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
Email	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
Email	watarutaru_328@yahoo.co.jp

Sponsor
Institute	Awaji medical center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051589