UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006166
Receipt number R000007287
Scientific Title Clinical determination of therapeutic angiogenesis by radionuclide image
Date of disclosure of the study information 2011/08/15
Last modified on 2016/02/19 16:12:32

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Basic information

Public title

Clinical determination of therapeutic angiogenesis by radionuclide image

Acronym

Clinical determination of angiogenesis by radionuclide image

Scientific Title

Clinical determination of therapeutic angiogenesis by radionuclide image

Scientific Title:Acronym

Clinical determination of angiogenesis by radionuclide image

Region

Japan


Condition

Condition

Peripheral Artery Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clinical blood flow examination after vascular regenerative therapy

Basic objectives2

Others

Basic objectives -Others

Diagnostic examination

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood flow recovery after treatment

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Radionuclide Image

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Medical refractory patients against conventional therapy, whom were performed vascular regenerative therapy.

Key exclusion criteria

1) no evidence of angiological stenosis confirmed by angiography, 2) history of vascular surgery (within 30 days), 3) presence of any malignant disease or history of its treatment within 5 years, 4) untreated proliferative diabetic retinopathy, 5) smoker unable to quit smoking, 6) drug addiction of any kind (including alcohol), 7) evidence of active viral infection, 8) infectious osteomyelitis, and 9) complication of any serious disease affecting the patient's general condition

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Gen Takagi

Organization

Nippon Medical School

Division name

Department of Cardiovascular Medicine

Zip code


Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Email

gen52@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Gen Takagi

Organization

Nippon Medical School

Division name

Department of Cardiovascular Medicine

Zip code


Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Homepage URL


Email

gen52@nms.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2011 Year 08 Month 15 Day


Related information

URL releasing protocol

http://jnm.snmjournals.org/content/57/2/192.long

Publication of results

Published


Result

URL related to results and publications

http://jnm.snmjournals.org/content/57/2/192.long

Number of participants that the trial has enrolled


Results

BMCI induced angiogenesis in the foot, which was detected using 99mTc-TF and 99mTc-MAA. 99mTc-MAA is a useful method to quantitate blood flow, estimate vascular size, and evaluate flow distribution after therapeutic angiogenesis.

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

Main results already published

Date of protocol fixation

2011 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date

2014 Year 01 Month 10 Day

Date of closure to data entry

2014 Year 02 Month 28 Day

Date trial data considered complete


Date analysis concluded

2014 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2011 Year 08 Month 13 Day

Last modified on

2016 Year 02 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007287


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name