Tokyo, July 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062210) titled 'Retrospective Study Using Clinical Information and Specimens in the Field of Cardiovascular Surgery' on July 13.
Study Type:
Observational
Primary Sponsor:
Institute - Osaka Medical and Pharmaceutical University
Condition:
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 malignancy - Others
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 1
days-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 Size - 5000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 13 Day
Anticipated trial start date - 2026 Year 07 Month 13 Day
Last follow-up date - 2046 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071191
Disclaimer: Curated by HT Syndication.
