UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study for preoperative factors to predict development of intimal hyperplasia in autologous vein graft.
Acronym	Predict IH
Scientific Title	Prospective study for preoperative factors to predict development of intimal hyperplasia in autologous vein graft.
Scientific Title:Acronym	Predict IH
Region	Japan

Condition
Condition	Arteriosclerosis obliterans Burger disease Arterial occlusion Traumatic arterial injury Collagen disease associated vasculitis etc.
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Although revascularization with high quality is needed in flourishing of vascular disease, intimal hyperplasia (IH) is still an unresolved issue of vein graft, a major substitute to rebuild circulation. Progressive IH occurs in 25% of vein graft, especially tending to develop in poor quality vein, however it is hard to preoperatively diagnose qualities of vein graft. Nothing has been established to predict IH development after bypass surgery. The aim of this study is to figure out predictors from preoperative blood and physiological test.
Basic objectives2	Others
Basic objectives -Others	Basic objectives are to understand mechanism of IH development, and to establish biomarkers which can predict IH development based on preoperative blood test including oxidative stress indicators, alarmin, and cytokines concentration, and mobilization of endothelial progenitor cells, and morphological, functional, and molecular biological test of surplus vein samples harvested during operation.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Occurrence of significant stenosis or occlusion of vein graft within one year after bypass surgery
Key secondary outcomes	Indicated below. 1) Major adverse cardiac events (MACE) 2) Major adverse limb events (MALE) 3) Postoperative death 4) Graft patency 5) Limb salvage rate 6) Ulcer healing rate

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) In routine care, patients with peripheral vascular disease needed autologous vein bypass grafting as operative material to rebuild circulation. 2) Patients 20 years of age and older who are able to agree with a will of theirs own.
Key exclusion criteria	1) Patients with lack in communication skills. 2) Patients who can not be followed for one year after bypass surgery. 3) Patients with extensive tissue loss proximally exceeding ankle joint. 4) Patients judged inadequate to join the study by attending doctor.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Nobuyoshi Middle name Last name Azuma
Organization	Asahikawa Medical University
Division name	Division of Vascular Surgery, Department of Surgery
Zip code	078-8510
Address	Midorigaoka-higashi 2-1-1-1, Asahikawa, 078-8510 Japan
TEL	0166-68-2494
Email	nazuma@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Shinsuke Middle name Last name Kikuchi
Organization	Asahikawa Medical University
Division name	Division of Vascular Surgery, Department of Surgery
Zip code	078-8510
Address	Midorigaoka-higashi 2-1-1-1, Asahikawa, 078-8510 Japan
TEL	0166-68-2494
Homepage URL
Email	kikuchi@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research B
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Asahikawa Medical University Research Ethics Committee
Address	Midorigaoka-higashi 2-1-1-1
Tel	0166682494
Email	kikuchi@asahikawa-med.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	2015 Year 09 Month 26 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	Enrolling by invitation
Date of protocol fixation	2015 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date	2015 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This is an observation study performed after vein graft bypass surgery. Basic objectives are to understand mechanism of IH development, and to establish efficient preoperative vein evaluation method and biomarkers which can predict IH development and major adverse cardiac events (MACE) based on some tests and patient back ground indicated below; 1) Relationship between preoperative blood test including oxidative and inflammatory stress indicators and vein endothelium functional disorder; 2) Relationship between number of preoperative blood endothelial progenitor cells and patient back ground or preoperative medicines; 3) Correlation between preoperative physiological vein test and intra-operative vein evaluation (morphology, function and gene expression); 4) Observation of postoperative development of intimal hyperplasia and occurrence of MACE. Study design: Cohort study Subject: All cases who visited the institute since 2/1/2015 matched with the selection criteria. Primary outcome: ccurrence of significant stenosis or occlusion of vein graft within one year after bypass surgery Secondary outcome (within one year after surgery): 1) Major adverse cardiac events (MACE) 2) Major adverse limb events (MALE) 3) Postoperative death 4) Graft patency 5) Limb salvage rate 6) Ulcer healing rate Examination 1) Preoperative blood test including oxidative stress indicators, alarmin, and cytokines concentration, 2) Mobilization of endothelial progenitor cells 3) Morphological, functional, and molecular biological test of surplus vein samples harvested during operation.

Management information
Registered date	2015 Year 09 Month 26 Day
Last modified on	2019 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022110