臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 18, 2024
Last modified on	Sept. 18, 2024
Trial ID	jRCT1052240127

Scientific Title	A study to elucidate the relationship and pathophysiology of left ventricular hypertrophy and worsening heart failure after TAVI from the perspective of coronary microvascular dysfunction
Public Title	Coronary microvascular dysfunction and heart failure after TAVI

Contact for Scientific Queries	Name	Nakazawa Gaku
	Affiliation	Kindai university hospital
	Address	377 2 Onohigashi Osakasayama city Osaka
	Telephone	+81-9019511351
	E-mail	koyumi514@gmail.com
Contact for Public Queries	Name	Fujita Kosuke
	Affiliation	Kindai university hospital
	Address	377 2 Onohigashi Osakasayama city Osaka
	Telephone	+81-9019511351
	E-mail	koyumi514@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 09, 2024
Actual date of first enrollment
Target sample size		30
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Adults aged 20 years or older Patients with severe aortic valve stenosis who are eligible for TAVI treatment and are scheduled for TAVI Patients with stenosis findings or suspected stenosis on coronary CT prior to TAVI Cases where informed consent has been obtained from the patient for participation in the study
	Exclusion Criteria	Presence of severe valvular disease (stenosis or regurgitation) other than aortic valve stenosis Patients who have undergone PCI during the pre-TAVI cardiac catheterization or are scheduled to undergo PCI postoperatively Patients deemed unsuitable for this study by the principal (or sub-investigator) physician
	Age Minimum	20age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Aortic stenosis, Heart failure, Coronary microvascular dysfunction
Intervention(s)
Health Condition(s) Keyword		AS, TAVI, CMD
Intervention(s) Keyword
Health Condition(s) Code		A07
Intervention(s) Code
Primary Outcome(s)		CFR and IMR as indicators of coronary microvascular dysfunction before and after TAVI
Secondary Outcome(s)		Evaluation of the correlation between wire-based IMR and angio-based IMR Transthoracic echocardiography: assessment of the severity of various valvular diseases and left ventricular mass index Cardiac MRI: assessment of left ventricular mass index and Late Gadolinium Enhancement (LGE)

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Ethics Committee of Kindai University Faculty of Medicine
Address	377-2 Ohnohigashi Osakasayama city, Osaka
Telephone	+81-723660221
E-Mail	koyumi514@gmail.com
Approval Status	Approval
Date of approval	Aug. 09, 2024

Plan to share IPD	Yes
Plan description	Personal information will be anonymized and protected. The data will be stored within the institution and securely safeguarded to prevent any external leakage. The data will be recorded on external storage media such as USB drives, using computers disconnected from the network, and securely stored under lock and key.

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none