UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015427 |
|---|---|
| Receipt number | R000017843 |
| Scientific Title | Prognostic Assessment for Patients Notified as Dual Obstructive Atherosclerosis Requiring Angioplasties |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2023/10/20 19:05:17 |
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Basic information
Public title
Prognostic Assessment for Patients Notified as Dual Obstructive Atherosclerosis Requiring Angioplasties
Acronym
PANDORA Registry
Scientific Title
Prognostic Assessment for Patients Notified as Dual Obstructive Atherosclerosis Requiring Angioplasties
Scientific Title:Acronym
PANDORA Registry
Region
| Japan |
Condition
Condition
Coronary artery disease, Carotid artery disease
Classification by specialty
| Medicine in general | Cardiology | Neurology |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the prognosis of patients complicating obstructive both coronary and carotid artery disease.
Basic objectives2
Others
Basic objectives -Others
prognostic assessment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
composite of adverse events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and revascularization for carotid or coronary artery)
Key secondary outcomes
all-cause death, non-fatal myocardial infarction, non-fatal stroke, and revascularization for carotid or coronary artery, admission due to congestive heart failure, and fatal arrhythmia
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Clinically stable patients who are scheduled coronary and/or carotid artery revascularization
Those who undergo both coronary computed tomography and carotid artery ultrasound for screening
Those who are willing to cooperate with us in the study
Those who can sign the informed consent document that is approved by the ethics committee of the medical institution participating in the study
Key exclusion criteria
Those who underwent coronary artery bypass grafting
Those who have severe chronic lidney disease (estimated glomerular filtration rate <30mL/min/1.73m2)
Those who have iodinated contrast medium allergy
Those who are not willing to participate in the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Sarai |
Organization
Fujita Health University
Division name
Cardiology
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192
TEL
0562-93-2312
msarai@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kawai |
Organization
Fujita Health University
Division name
Cardiology
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192
TEL
0562-93-2312
Homepage URL
hkawai@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Cardiology, Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
none
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
Fujita Health University IRB
Address
1-98 Dengakugakubo Kutsukake Toyoake
Tel
0562-93-2865
f-irb@fujita-hu.ac.jp
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
| 2014 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jat/25/10/25_42176/_article
Number of participants that the trial has enrolled
Results
The prevalence of TVD/LMT and HRP determined by coronary CTA is higher in patients needing CAS/CEA than in those without. Management of systemic atherosclerosis is required in the perioperative period of CAS/CEA.
Results date posted
| 2023 | Year | 04 | Month | 20 | Day |
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Partially published.
J Atheroscler Thromb. 2018 Oct 1;25(10):1022-1031.
J Cardiol. 2022 May;79(5):588
Management information
Registered date
| 2014 | Year | 10 | Month | 13 | Day |
Last modified on
| 2023 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017843
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
