UMIN-CTR Clinical Trial

Basic information
Public title	Prospective Ramdomized Trial of Extracranial-intracranial (EC-IC) Bypass Surgery for Adults with Moyamoya Disease with Hemorrhagic Onset
Acronym	Japanese Adult Moyamoya Trial (JAM Trial)
Scientific Title	Prospective Ramdomized Trial of Extracranial-intracranial (EC-IC) Bypass Surgery for Adults with Moyamoya Disease with Hemorrhagic Onset
Scientific Title:Acronym	Japanese Adult Moyamoya Trial (JAM Trial)
Region	Japan

Condition
Condition	Moyamoya disease
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of JAM Trial is to determine whether the combination of EC-IC bypass with risk factor modifications affects the prognosis and the incidence of recurrent bleeding attacks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	(1) recurrent bleeding (2) completed stroke causing significant morbidity in daily life activities (3) significant morbidity or mortality from other causes (4) the additional performance of EC-IC bypass by the decision of the participating neurologist such as in cases with progressive stroke, or crescendo TIA
Key secondary outcomes	The following events which occurs 3 months after enrollment: (1) recurrent bleeding on the same side of the previous bleeding (2) hemorrhage-related death or severe disability

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	EC-IC bypass on both sides (each side with some interval between). As the operative maneuver, the direct bypass procedures such as STA-MCA anastomosis are essential. A surgeon can add an indirect bypass procedure with direct bypass. Indirect bypass alone or high flow bypass graft such as venous graft or radial artery graft is not allowed.
Interventions/Control_2	Conservative therapy
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	16 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Clinical requirements. (1) Age: between 16 and 65 at the time of the initial bleeding episode. (2) Independent in their daily lives :modified Rankin disability scale 0-2 or 3 (supplement trial). (3) Intracerebral hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage within the preceding 12 months (4) At least one month should have passed after the last stroke episode, either ischemic or hemorrhagic. (5) At least one month should have passed after the completion of acute phase treatment for the hemorrhages and for the related secondary pathophysiology (e.g. hydrocephalus) . 2. Radiological requirements (1) CT/MRI (a) Lack of large infarction which widely spreads over the territory of a main arterial trunk. (b) Lack of contrast enhancement in the infracted area (2) Angiography (a) Angiographic findings should satisfy the diagnostic criteria of the spontaneous occlusion of the Circle of Willis (Moyamoya disease) published by the Ministry of Health, Labor and Welfare of Japan (b) No aneurysms are detected in major cerebral arteries.
Key exclusion criteria	(1) Not independent in daily lives (2) Atherosclerotic carotid disease, or cardiac arrhythmia which may cause thromboembolic complications (3) Malignant tumors or organ failure of the heart, liver, kidney, or lung (4) Unstable angina or has had a myocardial infarction within the past 6 months (5) Hematological abnormality showing bleeding diathesis (6) Uncontrolled diabetes showing a serum fasting blood glucose level of more than 300mg/dl, or requires insulin (7) Hypertension with the diastolic blood pressure of more than 110mmHg (8) Treated with EC-IC bypass surgery before enrollment (9) Pregnancy
Target sample size	160

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

Public contact
Name of contact person	1st name Middle name Last name Susumu Miyamoto
Organization	National Cardiovascular Center
Division name	Department of Neurosurgery, JAM Trial Office
Zip code
Address	5-7-1, Fujishirodai, Suita City, Osaka, Japan
TEL	06-6833-5012
Homepage URL
Email

Sponsor
Institute	JAM Trial executive and steering committee
Institute
Department

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

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	Completed
Date of protocol fixation	2000 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date	2001 Year 01 Month 01 Day
Last follow-up date	2013 Year 06 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2005 Year 09 Month 12 Day
Last modified on	2013 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000224

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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