UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047773 |
|---|---|
| Receipt number | R000054369 |
| Scientific Title | Analysis of the effect of the percutaneous coronary intervention on cardiopulmonary exercise test in patients with effort angina |
| Date of disclosure of the study information | 2022/06/20 |
| Last modified on | 2023/05/17 17:20:02 |
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Basic information
Public title
Analysis of the effect of the percutaneous coronary intervention (catheter-based therapy) on cardiopulmonary exercise test in patients with effort angina
Acronym
Analysis of the percutaneous coronary intervention on cardiopulmonary exercise test
Scientific Title
Analysis of the effect of the percutaneous coronary intervention on cardiopulmonary exercise test in patients with effort angina
Scientific Title:Acronym
Analysis of the percutaneous coronary intervention on cardiopulmonary exercise test
Region
| Japan |
Condition
Condition
Effort angina
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to assess whether cardiopulmonary exercise tests contribute to the early diagnosis of myocardial ischemia and evaluate the effect of the percutaneous coronary intervention on the results of cardiopulmonary exercise tests.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was defined as the changes of VO2/WR among the ischemia and control (non-ischemia) groups. The cardiopulmonary tests were scheduled before and within 3 months after (within 3 months) of the percutaneous coronary intervention.
Key secondary outcomes
The secondary endpoint was defined as the changes of VO2, VCO2, AT, Peak VO2, T1/2, VO2/HR, R, VE/VO2, VE/VCO2, and VE vs. VCO2 slope among the ischemia and control (non-ischemia) groups. The cardiopulmonary tests were scheduled before and after (within 3 months) of the percutaneous coronary intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Cardiopulmonary exercise tests are scheduled as non-invasive evaluations for patients whose effort angina is suspected. The method of exercise load is a warm-up of 4 minutes at rest and 4 minutes of 10W, followed by a linear ramp load with a bicycle ergometer that gradually increases at 20W per minute. Ischemia is judged based on ST-segment changes on the stress electrocardiogram performed at the same time. For ischemic-positive patients, the degree of anatomical stenosis is evaluated by coronary CT, stress myocardial perfusion imaging, and coronary angiography to confirm the presence or absence of significant stenosis. Moderate stenotic lesions were evaluated functional ischemia with fractional flow reserve (FFR), resting index, FFR angiography). For patients who are indicated for revascularization and who could undergo complete revascularization by percutaneous coronary intervention, second cardiopulmonary exercise tests are performed within 1 month (ischemic group).
Interventions/Control_2
The control group consists of patients whose ischemia was negative in the first cardiopulmonary exercise test. The second tests are performed in 1 to 3 months.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients suspected of exertional angina by medical interview, 12-leads electrocardiogram, chest X-ray, transthoracic echocardiography.
Key exclusion criteria
Cases with residual lesions, coronary artery bypass surgery, and heart failure symptom of NYHA functional classification II or higher are excluded. In addition, cases with moderate or higher valvular disease, cardiomyopathy, chronic atrial fibrillation or flatter, permanent pacemaker or implantable defibrillator, and lung disease are excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Otake |
Organization
Sakakibara Heart Institute
Division name
Inspection department
Zip code
1830003
Address
3-16-1, Asahi-cho, Fuchu-shi, Tokyo
TEL
042-314-3111
th2011tf@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Hiruma |
Organization
Sakakibara Heart Institute
Division name
Department of cardiology
Zip code
1830003
Address
3-16-1, Asahi-cho, Fuchu-shi, Tokyo
TEL
042-314-3111
Homepage URL
th2011tf@gmail.com
Sponsor or person
Institute
Sakakibara Heart Institute, Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
Sakakibara Heart Institute
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
Sakakibara Heart Institute
Address
3-16-1, Asahi-cho, Fuchu-shi, Tokyo
Tel
042-314-3111
thiruma@shi.heart.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
| 2022 | Year | 06 | Month | 20 | 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
2
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
| 2022 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 16 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054369
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