UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041924 |
|---|---|
| Receipt number | R000047704 |
| Scientific Title | Association between the trajectory of Ventricular Arterial Coupling and clinical outcomes in patients with severe Aortic Stenosis |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2024/08/27 21:59:54 |
* 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
Association between the trajectory of Ventricular Arterial Coupling and clinical outcomes in patients with severe Aortic Stenosis
Acronym
VACAS study
Scientific Title
Association between the trajectory of Ventricular Arterial Coupling and clinical outcomes in patients with severe Aortic Stenosis
Scientific Title:Acronym
VACAS study
Region
| Japan |
Condition
Condition
Aortic Stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate: (1) the relationship between hemodynamic parameters, including VAC, and prognosis of patient undergoing before and after surgery (SAVR/TAVI) , and (2) the relationship between hemodynamic parameters and prognosis in patients without surgery (SAVR/TAVI), and to evaluate the usefulness of VAC in patients with severe AS.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
First occurrence of death, development or progression of heart failure, or hospitalization for heart failure by the end of the study
Key secondary outcomes
(1) Individual incidences of death, development or exacerbation of heart failure, and heart failure hospitalization during the study period
(2) The occurrence of primary outcomes at 6, 12 and 24 months.
(3) Changes in ventricular artery coupling over time
(4) Comparison with existing prognostic indicators
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
Retrospective study
(1) Those who are 20 years of age or older at the time of obtaining consent
(2) Patients with severe aortic valve stenosis diagnosed by echocardiography (maximum velocity of blood flow through the aortic valve >=4.0 m/s by continuous wave Doppler, mean pressure gradient >=40 mmHg by simple Bernoulli formula, valve mouth area <=1.0 cm2, or valve mouth area coefficient <=0.6 cm2/m2 are met).
(3) A person who, after receiving a full explanation from the researcher, has obtained the subject's voluntary consent to participate in the study with a full understanding
Prospective study
Sergical treatment group
(1) Those who are 20 years of age or older at the time of obtaining consent
(2) Patients with severe aortic valve stenosis diagnosed by echocardiography (maximum velocity of blood flow through the aortic valve >=4.0 m/s by continuous wave Doppler, mean pressure gradient >=40 mmHg by simple Bernoulli formula, valve mouth area <=1.0 cm2, or valve mouth area coefficient <=0.6 cm2/m2 are met).
(3) Those who plan to have a radical cure within 3 months of registration.
(4) A person who, after receiving a full explanation from the researcher, has obtained the subject's voluntary consent to participate in this research with sufficient understanding.
Conservative treatment group
(1) Those who are 20 years of age or older at the time of obtaining consent
(2) Patients with severe aortic valve stenosis diagnosed by echocardiography (maximum velocity of blood flow through the aortic valve >=4.0 m/s by continuous wave Doppler, mean pressure gradient >=40 mmHg by simple Bernoulli formula, valve mouth area <=1.0 cm2, or valve mouth area coefficient <=0.6 cm2/m2 are met).
(3) Those who have not scheduled a radical cure within three months of registration
(4) A person who, after receiving a full explanation from the researcher, has obtained the subject's voluntary consent to participate in this research with sufficient understanding.
Key exclusion criteria
Retrospective study
(1) A person who has offered to refuse to cooperate in the research after disclosing information using the opt-out method
(2) Other persons who are deemed by the principal investigator to be unsuitable as research subjects
Prospective study
(1) Other persons who are deemed by the principal investigator to be unsuitable as research subjects
Target sample size
710
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nagai |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-706-6973
nagai@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Mizuguchi |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-706-6973
Homepage URL
mizu-tay@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Non profit foundation
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
Hokkaido University Faculty of Medicine and Graduate School of Medicine Independent Clinical Research Review Committee
Address
Kita 15 Nishi 7, Kita-ku, Sapporo, Hokkaido
Tel
011-706-5003
shomu@med.hokudai.ac.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
| 2020 | Year | 09 | Month | 30 | 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
| 2020 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047704
