UMIN-CTR Clinical Trial

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

cardiovascular disease

Classification by specialty

Medicine in general	Cardiology	Vascular surgery
Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name	Atsuko
Middle name
Last name	Nakayama

Organization

The university of Tokyo, Sakakibara Heart Institutue

Division name

Department of cardiology

Zip code

183-0003

Address

3-16-1, Asahi-Chou, Fuchu-City, Tokyo

TEL

0423143111

Email

atsukonakanaka@gmail.com

Name of contact person

1st name	Atsuko
Middle name
Last name	Nakayama

Organization

Cardiac rehabilitation

Division name

Department of cardiology

Zip code

183-0003

Address

3-16-1, Asahi-Chou, Fuchu-City, Tokyo

TEL

0423143111

Homepage URL

Email

atsukonakanaka@gmail.com

Institute

Sakakibara Heart Institute

Institute

Department

Personal name

Organization

Pfizer Health Research fundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Sakakibara Heart Institute

Address

3-16-1, Asahi-Chou, Fuchu-City, Tokyo

Tel

0423143111

Email

st

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Sakakibara　Heart Institute

Date of disclosure of the study information

2017

Year

07

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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).

Registered date

2017

Year

07

Month

29

Day

Last modified on

2023

Year

08

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032551