UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053060 |
|---|---|
| Receipt number | R000060529 |
| Scientific Title | Supervised Cardiac Rehabilitation of Patients with Angina, Nonobstructive Coronary Artery Disease, and Impaired Myocardial Flow Reserve: Quantification of Clinical Effects by 13N-Ammonia Positron Emission Tomography |
| Date of disclosure of the study information | 2024/10/27 |
| Last modified on | 2023/12/11 16:45:10 |
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Basic information
Public title
Supervised Cardiac Rehabilitation of Patients with Angina, Nonobstructive Coronary Artery Disease, and Impaired Myocardial Flow Reserve: Quantification of Clinical Effects by 13N-Ammonia Positron Emission Tomography
Acronym
Effects of Supervised Cardiac Rehabilitation
Scientific Title
Supervised Cardiac Rehabilitation of Patients with Angina, Nonobstructive Coronary Artery Disease, and Impaired Myocardial Flow Reserve: Quantification of Clinical Effects by 13N-Ammonia Positron Emission Tomography
Scientific Title:Acronym
Effects of Supervised Cardiac Rehabilitation
Region
| Japan |
Condition
Condition
Patients with angina and nonobstructive coronary artery disease associated with coronary microvascular dysfunction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exercise-based cardiac rehabilitation (CR) improves health-related quality of life and exercise capacity in patients with cardiovascular diseases. However, CR efficacy in patients with angina and nonobstructive coronary artery disease (ANOCA) associated with coronary microvascular dysfunction (CMD) remains unclear. We aimed to examine whether the multidisciplinary CR program is associated with improvements in CMD, symptomatic status, and exercise capacity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of 5-month exercise-based cardiac rehabilitation on PET-derived MFR, symptomatic status, and exercise capacity in patients with ANOCA.
Key secondary 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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We included 32 consecutive patients with ANOCA and impaired MFR, assessed using 13N-ammonia myocardial perfusion PET at our heart center, between November 2018 and November 2022.
Key exclusion criteria
The myocardial perfusion PET examinations, assessments of symptomatic status using the Seattle Angina Questionnaire (SAQ)-77 and exercise capacity using cardiopulmonary exercise testing (CPX), were conducted at baseline and 5-month follow-up for all study patients. Three patients refused these follow-up visits and were excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Miura |
Organization
Sapporo Kojinkai Memorial Hospital
Division name
Department of Cardiology
Zip code
0630052
Address
2-1-16-1 Miyanosawa, Nishi-ku, Sapporo 063-0052, Japan
TEL
011-665-0020
s.miura@sap-kojk.jp
Public contact
Name of contact person
| 1st name | Shiro |
| Middle name | |
| Last name | Miura |
Organization
Sapporo Kojinkai Memorial Hospital
Division name
Department of Cardiology,
Zip code
0630052
Address
2-1-16-1 Miyanosawa, Nishi-ku, Sapporo 063-0052, Japan
TEL
011-665-0020
Homepage URL
s.miura@sap-kojk.jp
Sponsor or person
Institute
Department of Cardiology, Sapporo Kojinkai Memorial Hospital
Institute
Department
Personal name
Shiro Miura
Funding Source
Organization
No funding source.
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
IRB in Sapporo Kojinkai Memorial Hospital
Address
2-1-16-1 Miyanosawa, Nishi-ku, Sapporo 063-0052, Japan
Tel
00810116650020
t_yamashita@cvc-ohno.or.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
| 2024 | Year | 10 | Month | 27 | 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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We included 32 consecutive patients with ANOCA and impaired MFR, assessed using 13N-ammonia myocardial perfusion PET at our heart center, between November 2018 and November 2022. A 5-month exercise-based CR program, along with appropriate medical interventions, including comprehensive patient education, lifestyle modifications, and management of cardiovascular risk factors, was proposed to them in our outpatient department at the first diagnosis. The myocardial perfusion PET examinations, assessments of symptomatic status using the Seattle Angina Questionnaire (SAQ)-77 and exercise capacity using cardiopulmonary exercise testing (CPX), were conducted at baseline and 5-month follow-up for all study patients. Three patients refused these follow-up visits and were excluded.
Management information
Registered date
| 2023 | Year | 12 | Month | 11 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060529
