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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000166 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Moyamoya disease | |
Classification by specialty |
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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 |
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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 | ||
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Eligibility | ||||
Age-lower limit |
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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 |
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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 |
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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 | |
Institute | JAM Trial executive and steering committee |
Institute | |
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Funding Source | |
Organization | Ministry of Health, Labor and Welfare |
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Nationality of Funding Organization | Japan |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Last modified on |
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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 | |
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Research case data | |
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