UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The survey of patients with aortic aneurysm/aortic dissection (multicenter study): characteristics, treatment, and prognosis, prospective observational study
Title of the study (Brief title)	The survey of patients with aortic aneurysm/aortic dissection (multicenter study), prospective observational study
Region	Japan

Condition
Condition	Aortic aneurysm/Aortic dissection
Classification by specialty	Cardiology Vascular surgery
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To examine causative disease, severity, treatment and prognosis of patients with aortic aneurysm/aortic dissection.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prognosis of patients with aortic aneurysm/aortic dissection (annual survey)
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who was diagnosed as aortic aneurysm or dissection 2) 20 years or older 3) The written informed consent provided by patients
Key exclusion criteria	1) Patients who retract the consent 2) Patients who cannot continue by complications
Target sample size	800

Research contact person
Name of lead principal investigator	Mitsuru Ohishi
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of cardiocascular medicine and hypertension
Address	8-35-1 Sakuragaoka, Kagoshima, Japan
TEL	099-275-5316
Email	ohishi@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Yuichi Akasaki
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of cardiocascular medicine and hypertension
Address	8-35-1 Sakuragaoka, Kagoshima, Japan
TEL	099-275-5318
Homepage URL
Email	yuichia@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	鹿児島大学病院

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 12 Day
Anticipated trial start date	2016 Year 08 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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	1) Causative disease (Marfan syndrome, Loeys-Dietz syndrome, Vascular Ehlers-Danlos syndrome) 2) Life style 3) Sleep disorders 4) Severity of Hypertension 5) Blood pressure, Pulse, Height, Body weight, Weist, Body temperature, WBC, RBC, Hb, Ht, Plt, BUN, Cre, UA, Na, K, Cl, T-bil, GOT, GPT, LDH, T-cho, TG, HDL, LDL-c, T-protein, Alb, FBS, HbA1C, CRP, BNP, NT-pro BNP, adiponectin, Omentin, indoxylsulfate, Wnt5a of PBMNC, Chest X-ray, ECG, ultrasonic cardiology, ultrasonography of carotid artery, baPWV, CT, baPWV(Pulse Wave Velocity), CAVI, AI, urine(Na, K, Cl, Cre, T-protein, Alb), polysomnography 6) Complications 7) Treatment

Management information
Registered date	2016 Year 05 Month 30 Day
Last modified on	2017 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025964