UMIN-CTR Clinical Trial

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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