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 2020/09/15 10:50:44

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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

Email

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


Email

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

Email

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

2020 Year 09 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047704


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name