UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047773
Receipt No. 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 2022/05/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email th2011tf@gmail.com

Sponsor
Institute Sakakibara Heart Institute, Department of Cardiology
Institute
Department

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
Email 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
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
2022 Year 05 Month 06 Day
Date of IRB
Anticipated trial start date
2022 Year 05 Month 20 Day
Last follow-up date
2027 Year 05 Month 06 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
2022 Year 05 Month 16 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054369

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.