UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000166 |
|---|---|
| Receipt number | R000000224 |
| Scientific Title | Prospective Ramdomized Trial of Extracranial-intracranial (EC-IC) Bypass Surgery for Adults with Moyamoya Disease with Hemorrhagic Onset |
| Date of disclosure of the study information | 2005/09/13 |
| Last modified on | 2013/07/11 13:02:54 |
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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
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
Sponsor or person
Institute
JAM Trial executive and steering committee
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000224
