UMIN-ICDS Clinical Trial

Public title

Retrospective Study Using Clinical Information and Specimens in the Field of Cardiovascular Surgery

Acronym

Retrospective Study Using Clinical Information and Specimens in the Field of Cardiovascular Surgery

Scientific Title

Retrospective Study Using Clinical Information and Specimens in the Field of Cardiovascular Surgery

Scientific Title:Acronym

Retrospective Study Using Clinical Information and Specimens in the Field of Cardiovascular Surgery

Region

Japan

Condition

Cardiovascular diseases and cardiovascular abnormalities. Specifically, the target conditions include ischemic heart disease, valvular heart disease, thoracic and abdominal aortic aneurysms, aortic dissection, peripheral vascular disease, congenital cardiovascular disease, structural heart disease associated with heart failure, other diseases requiring diagnosis, treatment, or follow-up in the cardiovascular field, and cardiovascular abnormalities detected by imaging or other tests.

Classification by specialty

Vascular surgery

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to retrospectively analyze clinical data, imaging findings, treatment and surgical records, pathological findings, laboratory results, and stored specimens obtained during routine clinical care from patients with cardiovascular diseases and cardiovascular abnormalities, and to clarify factors associated with disease pathophysiology, natural history, treatment outcomes, complications, and prognosis.

Through this study, we aim to understand the real-world practice of cardiovascular care and obtain findings that may support more appropriate clinical assessment, selection of treatment strategies, clinical management, and follow-up. The results will contribute to improvement in future patient care and to the accumulation of medical knowledge through academic presentations and publications.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Major clinical events include death, cardiovascular events, disease progression, surgery or therapeutic intervention, reintervention or retreatment, readmission, and clinically important complications. In patients undergoing surgery, perioperative major complications include surgical death, in-hospital death, stroke, re-exploration for bleeding, acute kidney injury or introduction of dialysis, severe infection, respiratory failure, heart failure, and reoperation.

Key secondary outcomes

1. Treatment outcomes and clinical course by disease, treatment strategy, or surgical procedure.

2. Surgical death, in-hospital death, postoperative complications, ICU length of stay, duration of mechanical ventilation, and postoperative hospital stay in patients undergoing surgery.

3. Disease progression, transition to therapeutic intervention, readmission, and long-term outcomes in patients managed with conservative treatment or follow-up.

4. Presence or absence of reoperation, reintervention, retreatment, and readmission.

5. Long-term death and occurrence of cardiovascular events.

6. Associations of imaging findings, clinical laboratory findings, surgical findings, pathological findings, and stored specimen findings with clinical course or postoperative outcomes.

7. Factors associated with complications, disease progression, and prognosis.

8. Clinical course, imaging findings, surgical findings, and pathological findings in rare diseases, rare complications, or untreated cardiovascular abnormalities.

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

1

days-old

<=

Age-upper limit

120

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Patients who received diagnosis, treatment, surgery, conservative treatment, or follow-up at this hospital for cardiovascular disease or cardiovascular abnormalities.

2. Patients who underwent surgery or perioperative management in our department, patients who were hospitalized or evaluated in our department but did not undergo surgery and were managed with conservative treatment or follow-up, or patients in whom cardiovascular abnormalities were detected by imaging or other tests during visits to other departments.

3. Patients aged 0 years or older and younger than 120 years at the time of registration.

4. Patients for whom existing information or specimens, including medical records, laboratory records, imaging studies, surgical records, anesthesia records, intensive care records, pathology records, outpatient records, or stored specimens, are available from routine clinical care.

5. Patients for whom retrospective analysis using medical records or related materials is possible.

Key exclusion criteria

1. Patients or their legally acceptable representatives who request refusal of research use.

2. Patients whose clinical information is markedly insufficient and for whom assessment of major analysis items is difficult.

3. For analyses using existing specimens, patients whose stored specimens are insufficient in condition or quantity and cannot be evaluated.

4. Patients whom the principal investigator or co-investigators judge to be inappropriate for inclusion in this study.

Target sample size

5000

Name of lead principal investigator

1st name	Masahiro
Middle name
Last name	Daimon

Organization

Osaka Medical and Pharmaceutical University

Division name

Department of Thoracic and Cardiovascular Surgery, Department of Surgery, Faculty of Medicine

Zip code

569-8686

Address

2-7 Daigaku-Machi, Takatsuki, Osaka, Japan

TEL

072-683-1221

Email

daimon@ompu.ac.jp

Name of contact person

1st name	Takuro
Middle name
Last name	Makiura

Organization

Osaka Medical and Pharmaceutical University

Division name

Department of Thoracic and Cardiovascular Surgery, Department of Surgery, Faculty of Medicine

Zip code

569-8686

Address

2-7 Daigaku-Machi, Takatsuki, Osaka, Japan

TEL

072-683-1221

Homepage URL

Email

takurou.makiura@ompu.ac.jp

Institute

Osaka Medical and Pharmaceutical University

Institute

Department

Personal name

Organization

Osaka Medical and Pharmaceutical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Osaka Medical and Pharmaceutical University

Address

2-7 Daigaku-Machi, Takatsuki, Osaka, Japan

Tel

072-683-1221

Email

takurou.makiura@ompu.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

2026

Year

07

Month

13

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

07

Month

13

Day

Date of IRB

Anticipated trial start date

2026

Year

07

Month

13

Day

Last follow-up date

2046

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a retrospective observational study of patients with cardiovascular diseases and cardiovascular abnormalities.First, patients identified as having cardiovascular disease or abnormalities will be extracted. Next, study subjects will be selected according to the eligibility and exclusion criteria. Patients who refuse research use of their information or specimens, or those whom the principal investigator or co-investigators judge to be inappropriate for this study, will be excluded. For eligible study subjects, information will be collected from medical records, laboratory records, imaging studies, surgical records, anesthesia records, intensive care records, pathology records, and outpatient clinical records obtained during routine clinical care. Collected information will include patient background, target disease, preoperative or diagnostic status, laboratory findings, imaging findings, surgical details, intraoperative findings, pathological findings, perioperative course, postoperative complications, reoperation or retreatment, and long-term outcomes. When surgical, pathological, blood, or other specimens collected during routine clinical care and stored after clinical use are available, these existing specimens may be used as needed to evaluate histological findings, inflammation, degeneration, fibrosis, calcification, thrombus, and infection-related findings, and to assess their association with clinical information. The study will not involve research-purpose clinic visits, new invasive procedures, interventions, additional tests, or new specimen collection. Collected information will be processed so that individuals cannot be directly identified before analysis. Subjects will be classified according to disease, treatment strategy (surgery or conservative treatment), severity, presence or absence of complications, specimen findings, prognosis, and other factors.

Registered date

2026

Year

07

Month

11

Day

Last modified on

2026

Year

07

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071191