UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050497 |
|---|---|
| Receipt number | R000057518 |
| Scientific Title | A Study of the Incidence of Myocardial Injury after Non cardiac Surgery in Non-dipper Hypertensive Patients: a single-center prospective observational study. |
| Date of disclosure of the study information | 2023/03/07 |
| Last modified on | 2026/05/24 07:26:19 |
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Basic information
Public title
A Study of the Incidence of Myocardial Injury after Non cardiac Surgery in Non-dipper Hypertensive Patients: a single-center prospective observational study.
Acronym
A Study of the Incidence of Myocardial Injury after Non cardiac Surgery in Non-dipper Hypertensive Patients: a single-center prospective observational study.
Scientific Title
A Study of the Incidence of Myocardial Injury after Non cardiac Surgery in Non-dipper Hypertensive Patients: a single-center prospective observational study.
Scientific Title:Acronym
A Study of the Incidence of Myocardial Injury after Non cardiac Surgery in Non-dipper Hypertensive Patients: a single-center prospective observational study.
Region
| Japan |
Condition
Condition
Myocardial injury after non cardiac surgery
Classification by specialty
| Cardiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate that patients with a non-dipping BP pattern show greater the change in hsTnT levels before and after surgery compared to patients with a dipping blood pressure pattern.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the change in hsTnT levels before and after surgery
Key secondary outcomes
the incidence of MINS, the incidence of PMI, and the occurrence of complications within 30 days after surgery
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing non cardiac surgery under general anesthesia at Chiba University Hospital, who have at least more than 3 risk factors for Myocardial Injury after Non-cardiac Surgery such as older than 75 years, male, atrial fibrillation, diabetes, hypertension, cardiac failure (history), coronary artery disease, peripheral vascular disease, renal dysfunction (eGFR<60), and stroke.
Key exclusion criteria
1. Emergency surgery
2. Repeat surgery during the same hospitalization
3. Cases with missing data
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomoharu |
| Middle name | |
| Last name | Ukiya |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL
043-222-7171
tomoharu.ukiya.915@gmail.com
Public contact
Name of contact person
| 1st name | Tomoharu |
| Middle name | |
| Last name | Ukiya |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL
043-222-7171
Homepage URL
tomoharu.ukiya.915@gmail.com
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Graduate School of Medicine
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
Tel
0432227171
tomoharu.ukiya.915@gmail.com
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
| 2023 | Year | 03 | Month | 07 | Day |
Related information
URL releasing protocol
https://journals.lww.com/anesthesiologyopen/fulltext/2026/04000/nondipping_blood_pressure_pattern_is
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/anesthesiologyopen/fulltext/2026/04000/nondipping_blood_pressure_pattern_is
Number of participants that the trial has enrolled
40
Results
Nondippers had a significantly greater increase in hs-cTnT after surgery than dippers (primary outcome: 7.0 [2.0 to 12.0] vs. 2.0 [0.5 to 4.0] ng/l; 95% CI for the difference, 1.0 to 9.0 ng/l; P = 0.008).
Results date posted
| 2026 | Year | 05 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Written informed consent was obtained from each subject after the aim and potential risks of the study were fully explained. In addition to the purpose of the study, participant criteria, the research funding source, the termination criteria, and the potential merits and risks were fully explained to the candidates. Participants were aged 40 yr or older, undergoing noncardiac surgery under general anesthesia at Chiba University Hospital, and had both hypertension and at least two additional independent predictors of MINS, such as male gender, 75 yr or older, coronary artery disease, heart failure, atrial fibrillation, cerebrovascular disease, diabetes mellitus, preoperative renal insufficiency, and peripheral arterial disease. The exclusion criteria were emergency procedures and planned extubation in the intensive care unit.
Participant flow
During the enrollment period of this study, 1,806 patients underwent noncardiac surgery under general anesthesia, of whom 312 (17.3%) had hypertension and three or more risk factors for MINS. Among these 312 patients, 40 patients were selected for inclusion based on availability for preoperative ABPM and sleep study, as well as the time availability of research members for complete data collection.
Adverse events
No notable findings
Outcome measures
The primary and secondary outcomes of this study were the change in hs-cTnT levels before and after surgery and the incidence of MINS.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 07 | Month | 10 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 01 | Day |
Other
Other related information
The purpose of this study was to clarify the incidence of MINS and postoperative complications in non-dipper hypertensive patients.
Management information
Registered date
| 2023 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057518
