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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000213
Receipt No. R000000283
Scientific Title Study of Circulating Progenitor Cells and Myocardial Infarction
Date of disclosure of the study information 2009/04/01
Last modified on 2005/09/13

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Basic information
Public title Study of Circulating Progenitor Cells and Myocardial Infarction
Acronym PROMIS
Scientific Title Study of Circulating Progenitor Cells and Myocardial Infarction
Scientific Title:Acronym PROMIS
Region
Japan

Condition
Condition Ischemic heart disease
Classification by specialty
Medicine in general Cardiology Vascular surgery
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To assess how much circulating progenitor cells are involved in the healing process of myocardial infarction
Basic objectives2 Others
Basic objectives -Others To assess how much circulating progenitor cells are involved in the healing process of myocardial infarction
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes number and function of circulating progenitor cells, cardiac function
Key secondary outcomes Differentiation pattern of circulating progenitor cells, cardiac perfusion images, hemodynamics

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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with ischemic heart disease
Key exclusion criteria cases without written consent
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Numaguchi
Organization Nagoya University
Division name Department of Cardiology
Zip code
Address 65 Tsurumai, Showa, Nagoya Japan
TEL 052-741-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Numaguchi
Organization Nagoya University
Division name Department of Cardiology
Zip code
Address 65 Tsurumai, Showa, Nagoya Japan
TEL 052-741-2111
Homepage URL
Email numa2@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization governmental grant
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
2009 Year 04 Month 01 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
Date of protocol fixation
2003 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2003 Year 07 Month 01 Day
Last follow-up date
2006 Year 01 Month 01 Day
Date of closure to data entry
2006 Year 06 Month 01 Day
Date trial data considered complete
2007 Year 06 Month 01 Day
Date analysis concluded
2007 Year 12 Month 01 Day

Other
Other related information Entry of 50 cases was confirmed.

Management information
Registered date
2005 Year 09 Month 13 Day
Last modified on
2005 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000283

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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