UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051527 |
|---|---|
| Receipt number | R000058774 |
| Scientific Title | In vivo and ex vivo microcirculation assessment in cardiac rehabilitation |
| Date of disclosure of the study information | 2023/07/10 |
| Last modified on | 2024/11/13 12:00:26 |
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Basic information
Public title
Verification of the Effect of Rehabilitation on Microcirculation in Patients with Cardiac Disease - An Observational Study -
Acronym
Verification of the Effect of Rehabilitation on Microcirculation in Patients with Cardiac Disease - An Observational Study -
Scientific Title
In vivo and ex vivo microcirculation assessment in cardiac rehabilitation
Scientific Title:Acronym
In vivo and ex vivo microcirculation assessment in cardiac rehabilitation
Region
| Japan |
Condition
Condition
cardiovascular disease
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of 3 months of cardiac rehabilitation on finger nail bed microcirculation and blood fluidity in patients with cardiovascular diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in finger nail bed microcirculation after 3 months of cardiac rehabilitation
Key secondary outcomes
Patient background,Cardiovascular test,Blood test,Blood fluidity test,Blood adhesion test,Sarcopenia evaluation,Physical evaluation,Expiratory gas test,Autonomic nerve test,Event survey
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are hospitalized at Dokkyo Medical University Nikko Medical Center and are prescribed cardiovascular rehabilitation
2)Patients aged 18 years or older at the time of informed consent
3)Patients who gave their written informed consent to participate in the study
Key exclusion criteria
1) Patients who are judged inappropriate for study participation by the attending physician
2) Patients who have difficulty walking
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Yasu |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Department of Cardiovasular Medicine and Nephrology
Zip code
3211298
Address
145-1 Moritomo, Nikko City, Tochigi Prefecture
TEL
0288237000
t-masato@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Terashima |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Department of Rehabilitation
Zip code
3211298
Address
145-1 Moritomo, Nikko City, Tochigi Prefecture
TEL
0288237000
Homepage URL
t-masato@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Nikko Medical Center
Institute
Department
Personal name
Funding Source
Organization
Dokkyo International Medical Education and Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University Nikko Medical Center Bioethics Committee
Address
145-1 Moritomo, Nikko City, Tochigi Prefecture
Tel
0288237000
rinshokenkyu@dokkyomed.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
| 2023 | Year | 07 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2031 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2031 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2031 | Year | 07 | Month | 31 | Day |
Other
Other related information
Study design
Single center prospective observational study
Recruitment method
All patients admitted to Dokkyo Medical University Nikko Medical Center from November 11 2021 to December 31 2030 who meet the selection criteria
Measurement item
Baseline survey Visit 1
Age gender
Rehabilitation calculation disease
medical history
Coronary risk factors
NYHA classification
Height Weight BMI
Blood pressure Pulse
Blood test
In vivo evaluation of subungual microcirculation
Prescription drug information
Blood fluidity test
Echocardiography
ABI
FMD
Sarcopenia evaluation
Body evaluation
Breath gas test
Autonomic nerve test
Evaluation of blood viscosity in macro and micro vessels
Investigation 3 months after discharge Visit 2
NYHA classification
Weight BMI
Blood pressure Pulse
Blood test
Prescription drug information
In vivo evaluation of subungual microcirculation
Blood fluidity test
Echocardiography
Sarcopenia evaluation
Body evaluation
Breath gas test
Autonomic nerve test
Event research
Evaluation of blood viscosity in macro and micro vessels
Follow-up survey until the end of the study period Conducted every year from the time of discharge
Weight BMI
Blood pressure Ppulse
Blood test
Event research
Management information
Registered date
| 2023 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058774
