UMIN-ICDS Clinical Trial

Public title

Association between dose reduction of renin-angiotensin-aldosterone system inhibitors before coronary artery angiography and acute kidney injury: A propensity score-matched study

Acronym

Association between dose reduction of RAASis before CAG and AKI: A propensity score-matched study

Scientific Title

Association between dose reduction of renin-angiotensin-aldosterone system inhibitors before coronary artery angiography and acute kidney injury: A propensity score-matched study

Scientific Title:Acronym

Association between dose reduction of RAASis before CAG and AKI: A propensity score-matched study

Region

Japan

Condition

inpatients aged 18 or older who were prescribed RAASis for at least one month prior to admission and were undergoing CAG during hospitalization between April 2005 and March 2019. Only first admissions with CAG and those who had a creatinine measurement within 30 days prior to CAG were included in our study. To restrict the focus to patients at risk of AKI, only patients with an estimated glomerular filtration rate (eGFR) of 15-60 ml/min/1.73 m2 were included. To minimize the influence of acute myocardial infarction, unstable angina and the dosage of contrast media, we focused on patients undergoing CAG without percutaneous coronary intervention. Patients undergoing dialysis within 3 days after admission were excluded.

Classification by specialty

Medicine in general	Cardiology	Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study was to investigate the association between dose reduction of RAASis and AKI among patients undergoing CAG using a Japanese health care record database.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Acute kidney injury: an absolute increase in serum creatinine of >= 0.3 mg/dl from baseline, which was defined as the last measured serum creatinine level before CAG, within 48 hours or a relative increase in serum creatinine of >= 50% within 7 days

Key secondary outcomes

the need for dialysis
in-hospital mortality

Study type

Others,meta-analysis etc

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

inpatients aged 18 or older who were prescribed RAASis for at least one month prior to admission and were undergoing CAG during hospitalization between April 2005 and March 2019. Only first admissions with CAG and those who had a creatinine measurement within 30 days prior to CAG were included in our study. To restrict the focus to patients at risk of AKI, only patients with an estimated glomerular filtration rate (eGFR) of 15-60 ml/min/1.73 m2 were included. To minimize the influence of acute myocardial infarction, unstable angina and the dosage of contrast media, we focused on patients undergoing CAG without percutaneous coronary intervention.

Key exclusion criteria

Patients undergoing dialysis within 3 days after admission were excluded. Patients with missing values for the primary diagnosis were also excluded because the primary diagnosis was treated as one of the explanatory variables in a previous study and may influence the incidence of AKI.

Target sample size

Name of lead principal investigator

1st name	Masato
Middle name
Last name	Takeuchi

Organization

Graduate School of Medicine and Public Health, Kyoto University

Division name

Department of Pharmacoepidemiology

Zip code

606-8501

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan

TEL

0757539469

Email

takeuchi.masato.3c@kyoto-u.ac.jp

Name of contact person

1st name	Hiroyuki
Middle name
Last name	Hashimoto

Organization

Graduate School of Medicine and Public Health, Kyoto University

Division name

Department of Pharamacoepidemiology

Zip code

606-8501

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto, Japan

TEL

0757539469

Homepage URL

Email

hashimoto.hiroyuki.36w@st.kyoto-u.ac.jp

Institute

Graduate School of Medicine and Public Health, Kyoto University

Institute

Department

Personal name

Masato Takeuchi

Organization

Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (grant number: 20H03941)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto, Japan

Tel

0757534680

Email

ethcom@kuhp.kyoto-u.ac.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

2023

Year

04

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

2007

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

Completed

Date of protocol fixation

2023

Year

04

Month

13

Day

Date of IRB

2020

Year

02

Month

17

Day

Anticipated trial start date

2023

Year

04

Month

13

Day

Last follow-up date

2023

Year

04

Month

14

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The exposure of interest is the presence of a dose reduction in RAASis during the 3 days before CAG was performed. The definition of dose reduction in RAASis is the change in the ratio of the prescribed dose to the defined daily dose (dose/DDD), which is defined by the World Health Organization. We will calculate the dose/DDD of RAASis for all hospitalization days. We will calculate the propensity score (PS) for each patient to balance the baseline characteristics of each group. PSs are estimate using a logistic regression model.
The primary outcome is AKI defined as an absolute increase in serum creatinine of >= 0.3 mg/dl from baseline, which was defined as the last measured serum creatinine level before CAG, within 48 hours or a relative increase in serum creatinine of >= 50% within 7 days. The results are presented as odds ratios (ORs) and 95% confidence intervals (CIs). We define the main result as the OR in the PS-matched cohort.

Registered date

2023

Year

04

Month

12

Day

Last modified on

2023

Year

06

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057896