UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018005 |
|---|---|
| Receipt number | 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 15:21:17 |
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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
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
sakatayk@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Departments of Cardiovascular Medicine and Evidence-based Cardiovascular Medicine, Tohoku University Graduate School of Medicine / Tohoku Heart Failure Association
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020866
