UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058724 |
|---|---|
| Receipt number | R000067147 |
| Scientific Title | Scoping Review on the Impact of Daily Life in Patients with Ischemia with Non-Obstructive Coronary Arteries (INOCA) |
| Date of disclosure of the study information | 2025/08/07 |
| Last modified on | 2025/08/07 15:01:06 |
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Basic information
Public title
Scoping Review on the Impact of Daily Life in Patients with INOCA
Acronym
INOCA-Life Review
Scientific Title
Scoping Review on the Impact of Daily Life in Patients with Ischemia with Non-Obstructive Coronary Arteries (INOCA)
Scientific Title:Acronym
INOCA-Life SR
Region
| Japan |
Condition
Condition
(INOCA) Ischemia with Non-Obstructive Coronary Arteries
Classification by specialty
| Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This scoping review aims to comprehensively identify and map existing literature on the impact of ischemia with non-obstructive coronary arteries (INOCA) on patients' daily lives. The objective is to clarify the current research trends and scope, and to identify gaps and future research needs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In this scoping review, the following data will be extracted from each included study: the name(s) of the author(s) and the year of publication; the country in which the study was conducted; the study design and methodology; participant characteristics such as age and sex; the study objectives and the concepts examined; the measurement tools or indicators used; and the key findings related to the impact of INOCA on patients' daily lives.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Studies that include patients diagnosed with INOCA (Ischemia with Non-Obstructive Coronary Arteries), including microvascular angina, vasospastic angina, or coronary microvascular dysfunction.
Studies that examine the impact of INOCA on patients' daily lives, including physical, psychological, or social aspects.
Original research articles (qualitative, quantitative, or mixed-methods studies).
Key exclusion criteria
Studies not involving INOCA or its related conditions.
Studies not addressing the impact on daily life (e.g., only diagnostic or pathophysiological studies).
Editorials, letters, conference abstracts, and case reports.
Articles not available in full text.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | MOMOKA |
| Middle name | |
| Last name | TODA |
Organization
St. Luke's International University
Division name
Graduate School of Nursing, Major in Acute Care Nursing
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
03-3543-6391
25MN010@slcn.ac.jp
Public contact
Name of contact person
| 1st name | MOMOKA |
| Middle name | |
| Last name | TODA |
Organization
St. Luke's International University
Division name
Graduate School of Nursing, Major in Acute Care Nursing
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
03-3543-6391
Homepage URL
25MN010@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
N/A
Address
N/A
Tel
N/A
N/A
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
| 2025 | Year | 08 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This scoping review will be conducted based on the framework proposed by Arksey and O'Malley (2005), and further developed by Levac et al. (2010) and the Joanna Briggs Institute (2015). Reporting will follow the PRISMA-ScR guidelines. The review process includes the following five stages:
Identifying the research questions: The aim is to explore the impact of INOCA on patients' daily lives.
Identifying relevant studies: A systematic search will be conducted using PubMed, CINAHL, Cochrane Library, and Ichushi Web.
Study selection: Based on the PCC criteria (Participants: adults with INOCA, Concept: impact on daily life, Context: no restriction on setting), qualitative, quantitative, mixed-methods, observational studies, and case reports will be included. Two reviewers will independently screen articles using Rayyan QCRI; disagreements will be resolved through discussion or third-party arbitration.
Charting the data: Data will be extracted using a standardized form, including author(s), year, country, study design, participant characteristics, objectives, indicators used, and main findings.
Collating, summarizing, and reporting the results: Thematic analysis will be used to identify common patterns and topics, with visual presentation of findings. Subgroup analysis by region, gender, or study design will be considered if feasible.
This study does not require ethical approval; the listed approval date is provisional.
Management information
Registered date
| 2025 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067147
