![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | |||
Condition | patients with hypertension undergoing non-cardiac surgery (RCRI>1) | ||
Classification by specialty |
|
||
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 | ||||||
hiromail1979@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
|
||||||
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 | |||||||
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 |
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 |
|
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 |
|
||||||
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |