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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028435
Receipt No. R000032551
Scientific Title The Long-time Cardiac REhabilitation AMong patients with cardiovascular disease.
Date of disclosure of the study information 2017/07/29
Last modified on 2018/07/30

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Basic information
Public title The Long-time Cardiac REhabilitation AMong patients with cardiovascular disease.
Acronym L-CREAM study
Scientific Title The Long-time Cardiac REhabilitation AMong patients with cardiovascular disease.
Scientific Title:Acronym L-CREAM study
Region
Japan

Condition
Condition cardiovascular disease
Classification by specialty
Medicine in general Cardiology Vascular surgery
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The long-term effects of cardiac rehabilitation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The endpoint of this study is all death and major adverse cardiovascular events (MACE: composed of cardiac death, acute coronary syndrome, cerebral infarction, acute aortic syndrome, and hospitalization for heart failure) > 150 days after starting CR program. We performed separate analyses according to a landmark (cutoff) point of 150 days after starting CR program, therfore, the CR participants with events occurring < 150 days after starting CR program were excluded from this study to minimize the bias in comparing the outcomes of all groups.
Key secondary outcomes surgery for abdominal aortic aneurysm
Arrhythmia


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
120 years-old >=
Gender Male and Female
Key inclusion criteria All patients were Asian. From September 2004 to September 2015, patients participated in CR during hospitalization for percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), valvular surgery, congestive heart failure (CHF), aortic aneurysm, and dissecting aneurysm of the aorta (DA) at Sakakibara Heart Institute (Tokyo, Japan).
Key exclusion criteria The patients whose CR program was not completed for death or severe events including acute coronary syndrome and cerebral infarction within 150 days or could not continue program over 90 days for any other reasons including busy daily schedule were excluded from this study.
Target sample size 15000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuko Nakayama
Organization The university of Tokyo, Sakakibara Heart Institutue
Division name Department of cardiology
Zip code
Address 7-3-1, Hongou, Bunkyo-Ku, Tokyo
TEL 03-3815-5411
Email st7089-fki@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuko Nakayama
Organization Cardiac rehabilitation
Division name Department of cardiology
Zip code
Address 7-3-1, Hongou, Bunkyo-Ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email st7089-fki@umin.ac.jp

Sponsor
Institute Sakakibara Heart Institute
Institute
Department

Funding Source
Organization Pfizer Health Research fundation
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
Address
Tel
Email

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 Sakakibara Heart Institute

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 29 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 Open public recruiting
Date of protocol fixation
2004 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 09 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We conducted a cohort study on 9,981 patients receiving CR from Septenber 2004 to September 2015. The patients who had supervised CR consist of three groups according to their CR duration; up to acute phase (Phase I group), up to recovery phase (Phase II group), and up to maintenance phase (Phase III group). The mortality and major adverse cardiovascular event (MACE) were compared among three groups. Inverse probability weight (IPW) calculated from the propensity score for groups according to CR duration was used to balance the covariates.

The cohort study was approved by the ethical committees of the Sakakibara Heart Institute Hospital (16/09/2004), and re-approved in 2016 (approval ID 16-005).

Management information
Registered date
2017 Year 07 Month 29 Day
Last modified on
2018 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032551

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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