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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000171
Receipt No. R000000240
Scientific Title Japanese Extracranial-Intracranial Arterial Bypass Trial-2 Study
Date of disclosure of the study information 2005/09/13
Last modified on 2007/04/18

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Basic information
Public title Japanese Extracranial-Intracranial Arterial Bypass Trial-2 Study
Acronym JET-2 Study
Scientific Title Japanese Extracranial-Intracranial Arterial Bypass Trial-2 Study
Scientific Title:Acronym JET-2 Study
Region
Japan

Condition
Condition Symptomatic occlusion or stenosis of internal carotid artery or middle cerebral artery
Classification by specialty
Medicine in general Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This prospective study is designed to answer a question if there are potential candidates for extracranial-intracranial bypass surgery in patients with mild cerebral ischemia due to recently symptomatic occlusive lesions in the carotid artery territory.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.Completed stroke (Rankin disability scale3,4,5) 2.Vascular death 3.Death and severe disability of other causes 4.Bypass surgery requested by neurologists due to impending stroke on the ipsilateral side
Key secondary outcomes 1.Ipsilateral stroke (Rankin disability scale3,4,5) 2.Death due to ipsilateral stroke

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
73 years-old >=
Gender Male and Female
Key inclusion criteria Recently symptomatic cerebral ischemic attacks due to occlusive lesions in the carotid territory demonstrated by cerebral angiography or magnetic resonance angiography. Transient ischemic attack (TIA) or ischemic minor stroke in the hemispheric carotid territory on the side of the occlusive lesions. Most recent qualifying TIA or stroke occurring within 6 months prior to enrollment. Age less than or equal to 73 years old. Modified Rankin Scale: 0-2. Competent to give informed consent Computed tomography (CT) or MRI demonstrating no diffuse cerebral infarction or no enhancement after infusion of contrast agent. Angiography showing occlusion or severe stenosis of internal carotid artery or middle cerebral artery trunk (M1). Quantitative measurement of cerebral blood flow (CBF) by positron emission tomography (PET), single photon emission computed tomography (SPECT), xenon-CT performed at least 3 weeks after the most recent attack. Cerebrovascular reserve capacity (CVR) is defined as [(CBF after infusion of acetazolamide-rest CBF)/ rest CBF] X 100% Definition of Groups Mild cerebral ischemia is classified into 4 groups based on the rest CBF and CVR. A: 80%
Key exclusion criteria 1. Severe neurological conditions (Rankin disability scale 3,4,5) 2. Non-atherosclerotic vascular disease of caotid artery territory 3. Malignancy, renal insufficiency, heart failure, hepatic failure, renal failure 4. Acute myocardial infarction within previous 6months 5. Fasting glucose level > 300mg/dl, 6. Diastolic blood pressure >110mmHg 7. Artery to artery embolism 8. Cardioembolism 9. Acute, progressing or unstable neurological deficit
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Miyamoto
Organization National Cardiovascular Center
Division name Neurosurgery
Zip code
Address 5-7-1, Fujishiro-dai, Suita, Osaka, Japan
TEL 06-6833-5012
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koji Iihara
Organization National Cardiovascular Center
Division name Neurosurgery
Zip code
Address 5-7-1, Fujishiro-dai, Suita, Osaka, Japan
TEL 06-6833-5012
Homepage URL
Email kiihara@hsp.ncvc.go.jp

Sponsor
Institute JET-2 Study Group
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2005 Year 09 Month 13 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 No longer recruiting
Date of protocol fixation
2004 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 04 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded

Other
Other related information Enrolled patients receive antiplatelet agents for the following 2 years. The incidence of the endpoints are to be compared between subgroups. Neurocognitive function and CBF are estimated at regular intervals during 2 years after enrollment and these changes are compared between subgroups.Enrolled patients receive antiplatelet agents for following 2 years.

Management information
Registered date
2005 Year 09 Month 12 Day
Last modified on
2007 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000240

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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