UMIN-CTR Clinical Trial

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

Perioperative patients

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Chiba University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

10

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2022

Year

10

Month

27

Day

Last modified on

2022

Year

11

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056193