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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018005
Receipt No. R000020866
Scientific Title Predictors and Prognostic Impact of Post-Traumatic Stress Disorder After the Great East Japan Earthquake in Patients With Cardiovascular Disease.
Date of disclosure of the study information 2015/06/22
Last modified on 2015/06/22

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Basic information
Public title Predictors and Prognostic Impact of Post-Traumatic Stress Disorder After the Great East Japan Earthquake in Patients With Cardiovascular Disease.
Acronym CHART-2 Study: PTSD after the Great East Japan Earthquake.
Scientific Title Predictors and Prognostic Impact of Post-Traumatic Stress Disorder After the Great East Japan Earthquake in Patients With Cardiovascular Disease.
Scientific Title:Acronym CHART-2 Study: PTSD after the Great East Japan Earthquake.
Region
Japan

Condition
Condition Chronic Heart Failure / Post-traumatic Stress Disorder
Classification by specialty
Medicine in general Cardiology Psychosomatic Internal Medicine
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the prevalence, predictors and prognostic impacts of post-traumatic stress disorder (PTSD) after the Great East Japan Earthquake in patients with cardiovascular disease (CVD) in our CHART-2 study.
Basic objectives2 Others
Basic objectives -Others To examine the prevalence, predictors and prognostic impacts of post-traumatic stress disorder (PTSD) after the Great East Japan Earthquake in patients with cardiovascular disease (CVD) in our CHART-2 study.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Background, Prevalence, Prognosis
Key secondary outcomes

Base
Study type

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Additional Blood Sampling(5mL)
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 In patients with ACCF/AHA Stages B/C/D and/or those with coronary artery disease.
Key exclusion criteria None.
Target sample size 8823

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Shimokawa
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.
TEL +81-22-717-7153
Email shimo@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiko Sakata
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.
TEL +81-22-717-7153
Homepage URL
Email sakatayk@cardio.med.tohoku.ac.jp

Sponsor
Institute Departments of Cardiovascular Medicine and Evidence-based Cardiovascular Medicine, Tohoku University Graduate School of Medicine / Tohoku Heart Failure Association
Institute
Department

Funding Source
Organization Evidence-based Cardiovascular Medicine Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
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 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/circj/79/3/79_CJ-14-1403/_article
Number of participants that the trial has enrolled
Results
The prevalence of PTSD was 14.7% at 6 months after the Earthquake. Female sex, experiencing the Tsunami, property loss, poverty, and insomnia medication use were associated with PTSD. The patients with PTSD more frequently experienced a composite of death, acute myocardial infarction, stroke and heart failure (18.5% vs. 15.0%, P=0.035).
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
2006 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date
2006 Year 10 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

Management information
Registered date
2015 Year 06 Month 22 Day
Last modified on
2015 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020866

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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