UMIN-ICDS Clinical Trial

Public title

A study on the prevalence and prognosis of unrecognized myocardial infarction

Acronym

UMI meta-analysis

Scientific Title

Prevalence and prognosis of unrecognized myocardial infarction diagnosed by cardiac magnetic resonance imaging: a systematic review and meta-analysis

Scientific Title:Acronym

CMR-UMI meta-analysis

Region

Japan

Condition

Unrecognized myocardial infarction, coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Unrecognized myocardial infarction (UMI) detected by late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR) is suggested to be a poor prognostic factor for cardiovascular events. The objective of this study is to determine the prevalence of CMR-defined UMI across three different risk cohorts and to compare how the prevalence changes with accumulating risk factors. Furthermore, we aim to evaluate the prognostic impact of UMI to assess the clinical necessity of CMR screening.

Basic objectives2

Others

Basic objectives -Others

Evaluation of prevalence and prognosis

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Pooled prevalence of UMI and the risk of major adverse cardiovascular events (MACE) or all-cause mortality in the UMI-positive group across the following groups:
Group 1: General population cohort
Group 2: Patients with coronary artery disease risk factors (including diabetes, hypertension, dyslipidemia, smoking history, and end-stage renal disease/dialysis)
Group 3: Patients with known coronary artery disease but no prior history of myocardial infarction

Key secondary outcomes

Comparison of UMI prevalence according to differences in risk factors and groups.

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Observational or cohort studies evaluating LGE using CMR that report the prevalence or prognosis of unknown ischemic LGE.

Key exclusion criteria

- Studies exclusively enrolling patients with a known history of myocardial infarction (recognized MI).
- Studies that include patients with recognized MI in the cohort, but do not provide separate data for unrecognized MI (UMI) and recognized MI, thereby precluding the extraction of UMI-specific prevalence or prognosis.
- Studies not using CMR to define UMI (e.g., defined solely by abnormal Q waves on electrocardiogram).
- Case reports, review articles, and animal studies.

Target sample size

30

Name of lead principal investigator

1st name	Naka
Middle name
Last name	Saito

Organization

Kanagawa Chidren's Medical Center

Division name

Department of Clinical Laboratory

Zip code

232-8555

Address

2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa 232-8555, Japan

TEL

045-711-2351

Email

naka.s.n.5@gmail.com

Name of contact person

1st name	Naka
Middle name
Last name	Saito

Organization

Kanagawa Children's Medical Center

Division name

Department of Clinical Laboratory

Zip code

232-8555

Address

2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa 232-8555, Japan

TEL

045-711-2351

Homepage URL

Email

naka.s.n.5@gmail.com

Institute

Kanagawa Children's Medical Center

Institute

Department

Personal name

Naka Saito

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Kanagawa Children's Medical Center

Address

2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa 232-8555, Japan

Tel

045-711-2351

Email

naka.s.n.5@gmail.com

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

2026

Year

09

Month

14

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

Preinitiation

Date of protocol fixation

2026

Year

09

Month

11

Day

Date of IRB

Anticipated trial start date

2026

Year

09

Month

15

Day

Last follow-up date

2027

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a systematic review and meta-analysis of existing literature.

Search Databases: A comprehensive literature search will be conducted using databases including PubMed, Web of Science, and the Cochrane Library.

Data Synthesis: We will extract the prevalence of UMI in each predefined group, as well as the hazard ratios (HR) or relative risks (RR) for major adverse cardiovascular events (MACE) or all-cause mortality comparing UMI-positive and UMI-negative groups.

Statistical Analysis: Data will be pooled using a random-effects model. Statistical heterogeneity will be assessed using the I-square statistic.

Quality Assessment: Risk of bias in the included studies will be evaluated (e.g., using the Newcastle-Ottawa Scale).

Registered date

2026

Year

09

Month

14

Day

Last modified on

2026

Year

09

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072038