Unique ID issued by UMIN | UMIN000016908 |
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Receipt number | 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 20:27:34 |
Effects of bisoprolol transdermal patch for perioperative myocardial injury in patients undergoing non-cardiac surgery
(Multi center Randomized Control Trial)
MAMACARI study
Effects of bisoprolol transdermal patch for perioperative myocardial injury in patients undergoing non-cardiac surgery
(Multi center Randomized Control Trial)
MAMACARI study
Japan |
patients with hypertension undergoing non-cardiac surgery (RCRI>1)
Cardiology | Anesthesiology |
Others
NO
To evaluate the efficasy of bisoprolol transdermal patch for perioperative myocardial injury in patients undergoing non-cardiac surgery
Efficacy
rise in high sensitive Troponin T on one day after operation
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
The patient undergoing operation was given bisoprolol transdermal patch(4mg) before 1 week operation.
control
60 | years-old | <= |
Not applicable |
Male and Female
(a) Hyptertension
(b) operation with general anesthesia
(c) RCRI 2 or more
(d) age over 60 year old
(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
240
1st name | Hiroshi |
Middle name | |
Last name | Ito |
Okayama University Graduate School of Medicine
Department of Cardiovascular Medicine
700-8558
2-5-1 Shikatatyo Kitaku Okayama City
086-235-7351
hiromail1979@yahoo.co.jp
1st name | Hironobu |
Middle name | |
Last name | Toda |
Okayama University Graduate School of Medicine
Department of Cardiovascular Medicine
700-8558
2-5-1 Shikatatyo Kitaku Okayama City
086-235-7351
hiromail1979@yahoo.co.jp
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine
none
Other
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
2-5-1 Shikatatyo Kitaku Okayama City
086-235-6938
mae6605@adm.okayama-u.ac.jp
NO
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)
2015 | Year | 03 | Month | 25 | Day |
Unpublished
240
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).
2019 | Year | 04 | Month | 01 | Day |
Inclusion criteria includes, Age>60, Undergo elective, non-cardiac surgery with general anesthesia, with Hypertension, and High RCRI score 2 or more.
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)
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
Completed
2015 | Year | 03 | Month | 25 | Day |
2014 | Year | 10 | Month | 21 | Day |
2015 | Year | 05 | Month | 01 | Day |
2019 | Year | 03 | Month | 31 | Day |
2015 | Year | 03 | Month | 25 | Day |
2019 | Year | 04 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017679
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