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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017987
Receipt No. R000020844
Scientific Title Plasma CRP and life prognosis in Parkinson disease: a retrospective study
Date of disclosure of the study information 2015/06/19
Last modified on 2015/07/29

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Basic information
Public title Plasma CRP and life prognosis in Parkinson disease: a retrospective study
Acronym CRP-survival study
Scientific Title Plasma CRP and life prognosis in Parkinson disease: a retrospective study
Scientific Title:Acronym CRP-survival study
Region
Japan

Condition
Condition Parkinson disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the role of baseline CRP levels in prognosis of patients with Parkinson disease (PD).
Basic objectives2 Others
Basic objectives -Others life prognosis
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome measure was a survival time from the study enrollment to death.
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Consecutive patients with PD who were treated at the Department of Neurology, the National Regional Center for Neurological Disorders and National Hospital of Utano from March 2004 to November 2007 were enrolled, and the medical records were retrospectively reviewed. The diagnosis of PD was based on the United Kingdom Parkinson's disease Brain Bank Diagnostic Criteria. The inclusion enrolment criteria included PD patients free of any infection who underwent measurement of plasma CRP.
Key exclusion criteria Patients with any infections at 28 days around the blood sampling.
Target sample size 219

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Sawada
Organization Utano National Hospital
Division name Clinical Research Center
Zip code
Address 8 Ondoyamacho, Narutaki, Ukyoku, Kyoto
TEL 81-75-461-5121
Email sawada@unh.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyuki Sawada
Organization Utano National Hospital
Division name Clinical Research Center
Zip code
Address 8 Ondoyamacho, Narutaki, Ukyoku, Kyoto
TEL 81-75-461-5121
Homepage URL
Email sawada@unh.hosp.go.jp

Sponsor
Institute Utano National Hospital
Institute
Department

Funding Source
Organization Clinical Research Center, Utano National Hospital
Organization
Division
Category of Funding Organization
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
2015 Year 06 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0134118
Number of participants that the trial has enrolled
Results
Results
During the observation period 56 patients died. Baseline CRP was log-linearly associated with a risk of death in PD. Mean survival time was 3,149 (95% confidence interval; 3,009-3,289) days in patients with CRP =< 0.8mg/L (lower two thirds) and 2,620 (2,343-2,897) days in those with CRP > 0.8 mg/L (top third, p < 0.001, log-rank test). The adjusted hazard ratio (HR) per two-fold higher CRP concentration for all deaths was 1.29 (1.10-1.52), and after excluding PD-unrelated deaths, such as cancer or stroke, HR was 1.23 (1.01-1.49) (adjusted for age, sex, PD duration, modified Hohen-Yahr stages, MMSE scores, and serum albumin).

Conclusions
Baseline CRP concentrations were associated with the risk of death and predicted life prognosis of patients with PD. The associations were independent from PD duration, PD severity, cognitive function, ages, and nutritional conditions, suggesting the possibility that subclinical chronic inflammation is associated with a neurodegenerative process in PD.
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
2014 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A cohort of 313 patients with a mean age of 69.1 and mean PD duration of 7.9 years was retrospectively followed for a mean observation time of 1,753 days.CRP was measured when patients were not diagnosed with any infections, and levels were repetitively measured to investigate a tendency of "regression to mean." The primary outcome measure was a survival time from study enrollment to death.

Management information
Registered date
2015 Year 06 Month 19 Day
Last modified on
2015 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020844

Research Plan
Registered date File name
2015/06/19 研究計画書 CRP survival研究.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2015/06/19 data set.xlsx


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