UMIN-CTR Clinical Trial

Basic information
Public title	The effectiveness of ACE-Inhibitor for preventing pneumonia; Systematic review and meta-analysis
Acronym	The effectiveness of ACE-Inhibitor for preventing pneumonia; Systematic review and meta-analysis
Scientific Title	The effectiveness of ACE-Inhibitor for preventing pneumonia; Systematic review and meta-analysis
Scientific Title:Acronym	The effectiveness of ACE-Inhibitor for preventing pneumonia; Systematic review and meta-analysis
Region	Japan

Condition
Condition	Pneumonia
Classification by specialty	Medicine in general Pneumology Neurology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effectiveness of ACE inhibitors for prevention of pneumonia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of pneumonia(Duration: the longest follow-up of each primary study), Definition: the presence of new pneumonic changes in the chest x-ray and clinical signs of pneumonia; cough, fever, sputum production and pleuritic chest pain. we will also accept pneumonia as the original authors defined)
Key secondary outcomes	Mortality(Duration: the longest follow-up of each primary study) Withdrawal due to adverse effects(Duration: the longest follow-up of each primary study) Swallowing function(Duration: the longest follow-up of each primary study, Definition:Assessed by the Royal Brisbane Hospital Outcome Measure for Swallowing(RBHOMS) score, the dysphagia severity rating scale (DSRS), the functional oral intake scale (FOIS), the dysphagia outcome and severity scale (DOSS), or water swallowing tests)

Base
Study type	Others,meta-analysis etc

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Nothing
Key exclusion criteria	Nothing
Target sample size	0

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Tsunoda
Organization	Shiga University of Medical Science Hospital
Division name	Department of family medicine
Zip code	520-2192
Address	Seta Tsukinowa-cho, Otsu, Shiga, Japan
TEL	077-548-2929
Email	hidekit0731@gmail.com

Public contact
Name of contact person	1st name Hideki Middle name Last name Tsunoda
Organization	Shiga University of Medical Science Hospital
Division name	Department of family medicine
Zip code	520-2192
Address	Seta Tsukinowa-cho, Otsu, Shiga, Japan
TEL	077-548-2929
Homepage URL
Email	hidekit0731@gmail.com

Sponsor
Institute	Shiga University of Medical Science Hospital, Department of family medicine
Institute
Department

Funding Source
Organization	Shiga University of Medical Science Hospital, Department of family medicine
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	Shiga University of Medical Science Hospital
Address	Seta Tsukinowa-cho, Otsu, Shiga, Japan
Tel	077-548-2929
Email	hidekit0731@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	2020 Year 02 Month 07 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	Preinitiation
Date of protocol fixation	2020 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date	2020 Year 02 Month 07 Day
Last follow-up date	2022 Year 02 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

<Types of studies> We will include all randomized controlled trials(RCTs), quasi-RCTs and observational studies. <Search Methods for identification of studies> We will search the following databases for the relevant studies. the Cochrane Central Register of Controlled Trials(CENTRAL); MEDLINE via Ovid; EMBASE; We will also use the resources below. the World Health Organization International Clinical Trials Platform Search Portal(ICTRP) ClinicalTrials.gov We will also search reference lists of included studies and clinical practice guidelines(ACC/ AHA/ ESC/ ESH). <Assessment of risk of bias in included studies> RCTs will be assessed by two authors independently using Risk of Bias 2 tool. Quasi-RCT/ non-RCT/ Observational studies will be assessed using Newcasstle-Ottawa scale <Subgroup analysis and investigation of heterogeneity> We will perform subgroup analysis for the primary outcome (incidence of pneumonia) as follows. 1. Race: Asian or not 2. Patients with or without a history of stroke. 3. Patients with or without neurodegenerative diseases. 4. Age: Elderly patients(Studies that included a minority(<20%) of patients under 65 years old will be included.) or not. 5. Study follow-up: short (<= 3 months), intermediate (3 months to 24 months), or long term (> 24 months) <Sensitivity analysis> We will perform sensitivity analysis for the primary outcome as follows. 1. Exclusion of studies using imputed statistics. 2. Exclusion of studies using the diagnostic criteria of pneumonia other than the presence of new pneumonic changes in the chest x-ray and clinical signs of pneumonia; cough, fever, sputum production and pleuritic chest pain. 3. Using the effect estimates from univariable analyses instead of those from multivariable analyses <"Summary of findings" tables> We will present following results of the review in "Summary of findings" tables. 1. The incidence rate of pneumonia 2. Mortality 3. Withdrawal due to adverse effects 4. Swallowing function

Management information
Registered date	2020 Year 02 Month 07 Day
Last modified on	2020 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044803