UMIN-CTR Clinical Trial

Basic information
Public title	A study of relation between heart injury before, during and after surgery (excluding cardiac surgery), and long-term cardiovascular medications.
Acronym	Relation between myocardial injury and long-term cardiovascular medications study.
Scientific Title	A prospective study of myocardial injury after non-cardiac surgery, and long-term use of cardiovascular drugs.
Scientific Title:Acronym	MINS and long-term use of cardiovascular drugs study.
Region	Japan

Condition
Condition	Perioperative patients
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify whether long-term cardiovascular drug administration contributes to the reduction of MINS(Myocardial Injury after Non-cardiac Surgery) incidence.
Basic objectives2	Others
Basic objectives -Others	To clarify the factors with stronger association among the MINS high-risk factors.
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The use of preoperative cardiovascular drugs and the incidence rate of MINS.
Key secondary outcomes	To investigate the association of stronger factors among the MINS high risk factors; atrial fibrillation, DM, heart failure, ischemic heart disease, peripheral vascular disease, HT, CKD, and stroke. Intraoperative circulatory parameters and MINS incidence. Intraoperative exhaled carbon dioxide concentration and MINS incidence. Postoperative circulatory parameters and MINS incidence.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are scheduled general anesthesia at Chiba University Hospital, who also meet 3 or more of the following criteria: atrial fibrillation, diabetes, heart failure, ischemic heart disease, peripheral vascular disease, hypertension, renal dysfunction, and stroke.
Key exclusion criteria	1. Emergency surgery 2. Patients participating in other interventional studies 3. Cases with missing data
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Meika Middle name Last name Suzuki
Organization	Chiba University Hospital
Division name	Anesthesiology, Pain and Palliative Care Medicine
Zip code	260-8677
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
TEL	0432227171
Email	meika.kobayashi@gmail.com

Public contact
Name of contact person	1st name Meika Middle name Last name Suzuki
Organization	Chiba University Hospital
Division name	Anesthesiology, Pain and Palliative Care Medicine
Zip code	260-8677
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
TEL	0432227171
Homepage URL
Email	meika.kobayashi@gmail.com

Sponsor
Institute	Chiba University Hospital, Department of Anesthesiology, Pain and Palliative Care Medicine
Institute
Department

Funding Source
Organization	Chiba University Hospital
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	Chiba University Hospital, Observational Research Ethics Review Committee
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
Tel	0432227171
Email	hsp-kenkyujisshi@chiba-u.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

Other administrative information
Date of disclosure of the study information	2022 Year 10 Month 27 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
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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2022 Year 10 Month 11 Day
Date of IRB	2022 Year 10 Month 11 Day
Anticipated trial start date	2022 Year 11 Month 02 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Observation/inspection/survey/report agendum 1. Patient background: Age, gender, height, weight, underlying disease, oral medications, blood test findings, exercise tolerance, echocardiographic test results, and other information obtained from charts and interviews. 2. Data obtained from intraoperative anesthesia records (biological monitor and electronic anesthesia chart): intraoperative blood pressure, pulse rate, presence/absence/amount of use of nitrates, type and amount of vasopressors used (including amount of noradrenaline used), volume of fluid transfusion, and blood transfusion etc. 3. Postoperative data: Blood test findings such as high-sensitivity troponin T, postoperative biological monitor information such as blood pressure and pulse rate, postoperative complications, postoperative mortality, days of hospitalization, presence or absence of delirium, etc.

Management information
Registered date	2022 Year 10 Month 27 Day
Last modified on	2022 Year 11 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056193