UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058790 |
|---|---|
| Receipt number | R000067221 |
| Scientific Title | A prospective registry for coronary artery plaque analysis and long-term prognosis investigation in patients undergoing cardiac catheterization: Goryokaku hospital ALLiance for OPtimal intervention in Coronary Artery Disease (GALLOP-CAD) Trial |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/13 17:16:13 |
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Basic information
Public title
A prospective registry for coronary artery plaque analysis and long-term prognosis investigation in patients undergoing cardiac catheterization: Goryokaku hospital ALLiance for OPtimal intervention in Coronary Artery Disease (GALLOP-CAD) Trial
Acronym
GALLOP-CAD Trial
Scientific Title
A prospective registry for coronary artery plaque analysis and long-term prognosis investigation in patients undergoing cardiac catheterization: Goryokaku hospital ALLiance for OPtimal intervention in Coronary Artery Disease (GALLOP-CAD) Trial
Scientific Title:Acronym
GALLOP-CAD Trial
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the pathology of coronary artery disease at the patient and plaque levels
Basic objectives2
Others
Basic objectives -Others
To analysis coronary artery plaque and investigate long-term prognosis in patients undergoing cardiac catheterization
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical outcomes after cardiac catheterization: combined and individual clinical endpoints consisting of all-cause death, cardiovascular-related death, recurrence of angina or myocardial infarction, stroke (ischemic stroke, hemorrhagic stroke), renal outcomes (renal-related death, development of end-stage kidney disease, sustained decrease in estimated glomerular filtration rate), and bleeding events (based on the BARC classification)
Key secondary outcomes
Predictors of coronary artery plaque morphology and characteristic findings and their association with clinical 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent coronary angiography or percutaneous coronary intervention
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Fukase |
Organization
Hakodate Goryokaku Hospital
Division name
Department of Cardiology
Zip code
040-8611
Address
38-3, Goryokaku-cho, Hakodate-shi, Hokkaido, Japan
TEL
0138-51-2295
t.fukase.srm@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Fukase |
Organization
Hakodate Goryokaku Hospital
Division name
Department of Cardiology
Zip code
040-8611
Address
38-3, Goryokaku-cho, Hakodate-shi, Hokkaido, Japan
TEL
0138-51-2295
Homepage URL
t.fukase.srm@gmail.com
Sponsor or person
Institute
Hakodate Goryokaku Hospital, Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
Hakodate Goryokaku Hospital, Department of Cardiology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakodate Goryokaku Hospital institutional review board
Address
38-3, Goryokaku-cho, Hakodate-shi, Hokkaido, Japan
Tel
0138-51-2295
matsuyama@gobyou.com
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
函館五稜郭病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collection of cardiac catheterization and treatment results, as well as test results and patient information performed within the scope of routine clinical practice
Management information
Registered date
| 2025 | Year | 08 | Month | 13 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067221
