UMIN-CTR Clinical Trial

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

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

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Asahikawa Medical University

Institute

Department

Personal name

Organization

Grants-in-Aid for Scientific Research B

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Asahikawa Medical University Research Ethics Committee

Address

Midorigaoka-higashi 2-1-1-1

Tel

0166682494

Email

kikuchi@asahikawa-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

09

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2015

Year

09

Month

26

Day

Last modified on

2019

Year

10

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022110