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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06281054
Other study ID # SMC2023-12-027
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2002
Est. completion date December 31, 2024

Study information

Verified date February 2024
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Using national health insurance service database, current study aim to evaluate the risk and prognosis of acute myocardial infarction in cancer patients and to find the optimal treatment strategy for acute myocardial infarction that can improve long-term prognosis.


Description:

This study will be conducted using Korean National Health Insurance Service database. Patients who were diagnosed with cancer from 2002 to 2021 will be included in the study. Using the selected patients, current study will analyze the incidence and prognosis of acute myocardial infarction in cancer patients and the prognosis according to the treatment method for acute myocardial infarction will be compared. Primary outcome will be all-cause death. Secondary outcomes will be myocardial infarction, revascularization, hospitalization for heart failure, stroke, and clinically relevant bleeding.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 4500000
Est. completion date December 31, 2024
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients diagnosed with cancer between 2002 and 2021 - Patients who were diagnosed with acute myocardial infarction after cancer diagnosis Exclusion Criteria: - Patients who died during period of cancer diagnosis

Study Design


Intervention

Procedure:
Revascularization
Performing PCI or CABG

Locations

Country Name City State
Korea, Republic of Chonnam National University Hospital, Chonnam National University Medical School Gwangju

Sponsors (2)

Lead Sponsor Collaborator
Samsung Medical Center Chonnam National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause death All-cause death which was obtained from death certification collected by Statistics Korea at the Ministry of Strategy and Finance of South Korea 2-years after diagnosis of acute myocardial infarction
Secondary Myocardial infarction Myocardial infarction is defined as presence of the diagnostic codes (ICD-10 I21, I22) in the primary position during hospitalization 2-years after diagnosis of acute myocardial infarction
Secondary Revascularization Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) 2-years after diagnosis of acute myocardial infarction
Secondary Hospitalization for heart failure Heart failure events requiring hospitalization defined as presence of the diagnostic codes (I110, I130, I132, I255, I420, I425-I429, I43, I50, I971) in the primary position during hospitalization 2-years after diagnosis of acute myocardial infarction
Secondary Stroke Stroke is defined as ischemic stroke (ICD-10 I63, I64) or intracranial hemorrhage (ICD-10 I60-62), combined with the codes of diagnostic brain imaging. 2-years after diagnosis of acute myocardial infarction
Secondary Clinically relevant bleeding Bleeding requiring hospitalization or transfusion 2-years after diagnosis of acute myocardial infarction
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