UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052364 |
|---|---|
| Receipt number | R000059618 |
| Scientific Title | Effectiveness of Cardiac Rehabilitation for Secondary Prevention of Myocardial Infarction : Investigation using coronary CT and cardiopulmonary stress test |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2023/10/01 11:03:34 |
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Basic information
Public title
Effectiveness of Cardiac Rehabilitation for Secondary Prevention of Myocardial Infarction
Acronym
Cardiac Rehabilitation for Secondary Prevention of Myocardial Infarction
Scientific Title
Effectiveness of Cardiac Rehabilitation for Secondary Prevention of Myocardial Infarction : Investigation using coronary CT and cardiopulmonary stress test
Scientific Title:Acronym
Cardiac Rehabilitation for Secondary Prevention of Myocardial Infarction
Region
| Japan |
Condition
Condition
Acute Coronary Syndrome
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether cardiac rehabilitation is useful in preventing recurrence (secondary prevention) in patients with acute coronary syndromes (acute myocardial infarction and unstable angina) by evaluating the presence of plaque extension on coronary CT over time.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plaque extension on coronary CT one year after the onset of acute coronary syndrome compared to immediately after the onset of acute coronary syndrome.
Key secondary outcomes
Cardiovascular events: all-cause mortality, cardiac death, acute coronary syndrome, angina requiring hospitalization, heart failure requiring hospitalization
CT findings: changes in non-calcified plaque volume and pericardial fat in plaque quantitative evaluation
Rehabilitation indices: change in cardiac anaerobic metabolic threshold (AT), maximal oxygen uptake (peak VO2), and muscle mass
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 admitted to Fujita Health University Hospital with acute coronary syndromes who underwent PCI or who were judged not to require invasive treatment.
Patients who have given their free and voluntary written consent to participate in this study after receiving full explanation and with full understanding.
Patients 20 years of age or older at the time consent is obtained
Key exclusion criteria
1. Cases of acute coronary syndrome in which the lesion responsible for this acute coronary syndrome did not undergo the necessary revascularization procedures and remained as an obstructive lesion.
2. Cases after coronary artery bypass grafting
3. Cases in which CT imaging is not possible due to allergy to contrast agent
4. Cases with estimated glomerular filtration rate (eGFR) <30
5. Cases with pregnant or lactating women
6. Patients deemed by the attending physician to be unsuitable for participation in the study (including issues with imaging conditions)
7. Patients deemed inappropriate by the Principal Investigator or Principal Investigator for other reasons
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Kawai |
Organization
Fujita Health University
Division name
Department of Cardiology
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-2312
hkawai@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kawai |
Organization
Fujita Health University
Division name
Department of Cardiology
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-2312
Homepage URL
hkawai@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
MEXT: Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Medical University Medical Research Ethics Review Committee
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
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
| 2023 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Within 1 month after admission: blood tests, cardiopulmonary exercise testing, coronary CT
One year after the first CT: blood test, cardiopulmonary exercise testing, coronary CT
Management information
Registered date
| 2023 | Year | 10 | Month | 01 | Day |
Last modified on
| 2023 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059618
