UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045415 |
|---|---|
| Receipt number | R000051787 |
| Scientific Title | Prospective Registry of STable Angina RehabiliTation: Pilot Study |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/09/09 17:05:43 |
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Basic information
Public title
Prospective Registry of STable Angina RehabiliTation: Pilot Study
Acronym
Pre-START Study
Scientific Title
Prospective Registry of STable Angina RehabiliTation: Pilot Study
Scientific Title:Acronym
Pre-START Study
Region
| Japan |
Condition
Condition
Stable coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy, including health-related quality of life, exercise capacity, and cardiovascular events, and safety of cardiac rehabilitation in Japanese patients with stable coronary artery disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Seattle Angina Questionnaire (SAQ)-7 summary score at 6 months
Key secondary outcomes
Following outcomes at 6 months
1. Subscores of the three items of the Seattle Angina Questionnaire (SAQ)-7 (physical limitation, angina frequency, quality of life)
2. Summary score of the SF-12 (Physical component summary [PCS], Mental component summary [MCS], Role/Social component summary [RCS]) and sub-scores (Physical functioning [PF], Role physical [RP], Bodily pain [BP], General health [GH], Vitality [VT], Social functioning [SF], Role emotional [ RE], Mental health [MH])
3. Summary score of Hospital and Anxiety Depression Scale (HADS) (HADS-Depression [D], HADS-Anxiety [D])
4. Composite outcome of all-cause mortality and myocardial infarction
5. all-cause mortality
6. Cardiac death
7. Myocardial infarction
8. Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG])
9. Hospitalization for heart failure
10. Exercise capacity (Peak VO2, anaerobic threshold [AT], peak work rate [WR], exercise time to >1 mm ST depression)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
All patients attend outpatient cardiac rehabilitation (CR) after a cardiopulmonary exercise stress test. All patients will be required to participate in at least 36 sessions of outpatient cardiac rehabilitation. Exercise uses a bicycle ergometer, and resistance training is left to each facility. Other forms of exercise such as treadmill walking, upper body exercise using an upper limb ergometer, dance, aquatic exercise, and high-intensity interval training etc., are not allowed. Each exercise session will consist of a 5-10 minute warm-up, main exercise (aerobic or resistance training), and a 5-10 minute cool-down.
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
1. Willing to provide written informed consent
2. Age 20 years or higher
3. Have angina symptoms with CCS classification I-III or asymptomatic myocardial ischemia
4. Have Significant myocardial ischemia on SPECT, PET, stress echocardiography, or stress perfusion MRI; or significant coronary artery stenosis (>90% stenosis or >50%
stenosis with positive results in fractional flow reserve or resting indices) among major coronary arteries on invasive coronary angiography
Key exclusion criteria
1. Acute coronary syndrome, including unstable angina with CCS classification IV
2. Three-vessel coronary artery disease
3. Left main coronary artery disease
4. Myocardial infarction within 6 months
5. Coronary artery revascularization within 6 months
6. Contraindication to antiplatelets
7. Left bundle branch block or Wolff-Parkinson-White syndrome
8. NYHA class III-IV heart failure at entry or hospitalization for exacerbation of heart failure within 6 months
9. Left ventricular ejection fraction < 35%
10. Pulmonary hypertension requiring drug therapy
11. Moderate or severe valvular heart disease or previous surgical/percutaneous treatment for valvular heart disease
12. Dilated or hypertrophic cardiomyopathy
13. Moderate or severe aortic aneurysm
14. Cardiac implantable electronic device including pacemaker, implantable cardioverter defibrillator, or biventricular pacemaker implantation
15. Left or right ventricular assist device or heart transplantation
16. Unable to exercise due to musculoskeletal disease or peripheral arterial disease
17. Terminal illness
18. Pregnant or lactating women
19. Estimated glomerular filtration rate <30 mL/min/1.73 m2, maintenance dialysis, peritoneal dialysis, or post-renal transplantation
20. Severe dementia
21. Home is far away from an outpatient cardiac rehabilitation center
22. Participating in another clinical trial involving interventions
23. Treating physician judged it inappropriate to participate in the study
24. Do not understand the Japanese language
25. Study researchers and their family members
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Satoaki |
| Middle name | |
| Last name | Matoba |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Cardiovascular Medicine, Graduate School of Medical Science,
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
075-251-5111
matoba@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Tomotsugu |
| Middle name | |
| Last name | Seki |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Cardiovascular Medicine, Graduate School of Medical Science,
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
075-251-5111
Homepage URL
tseki@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Ethics Committee, Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan
Tel
075-251-5111
rinri@koto.kpu-m.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
京都府立医科大学(京都府), 群馬県立心臓血管センター(群馬県), 枚方公済病院(大阪府),佐久医療センター(長野県), 洛和会音羽病院(京都府), 聖マリアンナ医科大学(神奈川県), 明石医療センター(兵庫県), 京都大学(京都府), 兵庫県立尼崎総合医療センター(兵庫県), 九州医療センター(福岡県), 順天堂大学(東京都)、昭和大学(東京都)、神戸市立医療センター中央市民病院(兵庫県)、天理よろづ相談所病院(奈良県)、京都きづ川病院(京都府)、林ハートクリニック(京都府)、立石クリニック(京都府)、勝目医院(京都府)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1253/circrep.CR-22-0131
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
8
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051787
