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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016908
Receipt No. R000017679
Scientific Title Effects of bisoprolol transdermal patch for perioperative myocardial injury in patients undergoing non-cardiac surgery (Multi center Randomized Control Trial)
Date of disclosure of the study information 2015/03/25
Last modified on 2019/04/01

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Basic information
Public title Effects of bisoprolol transdermal patch for perioperative myocardial injury in patients undergoing non-cardiac surgery
(Multi center Randomized Control Trial)
Acronym MAMACARI study
Scientific Title Effects of bisoprolol transdermal patch for perioperative myocardial injury in patients undergoing non-cardiac surgery
(Multi center Randomized Control Trial)
Scientific Title:Acronym MAMACARI study
Region
Japan

Condition
Condition patients with hypertension undergoing non-cardiac surgery (RCRI>1)
Classification by specialty
Cardiology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficasy of bisoprolol transdermal patch for perioperative myocardial injury in patients undergoing non-cardiac surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes rise in high sensitive Troponin T on one day after operation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patient undergoing operation was given bisoprolol transdermal patch(4mg) before 1 week operation.
Interventions/Control_2 control
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (a) Hyptertension
(b) operation with general anesthesia
(c) RCRI 2 or more
(d) age over 60 year old
Key exclusion criteria (a) treated with beta blocker before randamization
(b)contraindication for beta blocker(c) absolute indication for beta blocker including severe myocardial ischemia and severe tachycardia (d) planning for PCI or CABG in study period (e) End stage renal disease eGFR<15 or dialysis
Target sample size 240

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Ito
Organization Okayama University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code 700-8558
Address 2-5-1 Shikatatyo Kitaku Okayama City
TEL 086-235-7351
Email hiromail1979@yahoo.co.jp

Public contact
Name of contact person
1st name Hironobu
Middle name
Last name Toda
Organization Okayama University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code 700-8558
Address 2-5-1 Shikatatyo Kitaku Okayama City
TEL 086-235-7351
Homepage URL
Email hiromail1979@yahoo.co.jp

Sponsor
Institute Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1 Shikatatyo Kitaku Okayama City
Tel 086-235-6938
Email mae6605@adm.okayama-u.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 岡山大学病院（岡山県）姫路赤十字病院（兵庫県）、福山市民病院（広島県）、津山中央病院（岡山県）、岡山医療センター（岡山県）

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 25 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 240
Results 
The rate of PMI was 35.7% in bisoprolol group and 44.5% in control group respectively.(P=0.18) Major adverse cardiac events including non-critical myocardial infarction and strokes were similar between two groups(bisoprolol group:2.7%, control group:2.7%). Tachyarrhythmia, including new onset of atrial fibrillation and other tachyarrhythmia requiring any treatment within 30-days after surgery, was higher in control group(bisoprolol group:6.3%, control group:13.6% P=0.07).
Results date posted
2019 Year 04 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Inclusion criteria includes, Age>60, Undergo elective, non-cardiac surgery with general anesthesia, with Hypertension, and High RCRI score 2 or more.
Participant flow 
240 patients were randomly assigned to bisoprolol patch group and control group.
Inclusion criteria includes, Age>60, Undergo elective, non-cardiac surgery with general anesthesia, with Hypertension, and High RCRI score 2 or more
Exclusion criateria includes, already treated with beta blocker, contraindication for beta blocker(ex. shock status, bradycardia less than 40bpm), absolute indication for beta blocker(symptom of ischemia or tachyarrhythmia)
, and with severe chronic kidney disease (eGFR<15 ml/min/1.73 m2 or dialysis)
Adverse events
Outcome measures 
Primary efficacy outcome:Incidence of PMI
Secondary endpoints
30-days all cause mortality 
Cardiovascular events(non-critical MI, Stroke)
Tachyarrhythmia including atrial fibrillation 

Safety endpoints related to bisoprolol patch include hypotension and bradycardia
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 03 Month 25 Day
Date of IRB
2014 Year 10 Month 21 Day
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 25 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017679

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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