UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022527 |
|---|---|
| Receipt number | R000025964 |
| Scientific Title | The survey of patients with aortic aneurysm/aortic dissection (multicenter study): characteristics, treatment, and prognosis, prospective observational study |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2017/11/30 20:57:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The survey of patients with aortic aneurysm/aortic dissection (multicenter study): characteristics, treatment, and prognosis, prospective observational study
Acronym
The survey of patients with aortic aneurysm/aortic dissection (multicenter study), prospective observational study
Scientific Title
The survey of patients with aortic aneurysm/aortic dissection (multicenter study): characteristics, treatment, and prognosis, prospective observational study
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Mitsuru Ohishi |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of cardiocascular medicine and hypertension
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5316
ohishi@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Akasaki |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of cardiocascular medicine and hypertension
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5318
Homepage URL
yuichia@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2016 | Year | 04 | Month | 12 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025964
