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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06357000
Other study ID # Time from PCI to surgery
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2008
Est. completion date December 31, 2018

Study information

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

Clinical Trial Summary

To evaluate the association between time from PCI to cancer surgery and cardiovascular and oncologic outcomes in early-stage cancer patients, A retrospective, population-based cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database.


Description:

Early-stage-cancer patients with a history of PCI who underwent cancer surgery (N = 3621) were included. The patients were divided into two groups based on the time between the dates of PCI and cancer surgery (<12 months and ≥12 months). Patients were stratified into early-surgery and late-surgery, defined as patients who underwent surgery ≥1 and <1 month after cancer diagnosis. Outcomes included bleeding, spontaneous myocardial infarction (MI), repeat revascularization, cancer recurrence, and death.


Recruitment information / eligibility

Status Completed
Enrollment 3621
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - men and women aged =18 years who were diagnosed with cancer and underwent cancer surgery within 1 year following diagnosis. - patients who underwent PCI (procedure code: M6551-M6572, O1640-O1649, OA640-OA649) prior to the cancer surgery Exclusion Criteria: - participants who received neoadjuvant or adjuvant treatment for cancer

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Occurence of Bleeding Bleeding requiring transfusion was defined by the transfusion codes (X2021, X2022, X2031, X2032, X2091, X2092, X2111, X2112, X2131, X2132). up to 5 years
Secondary Occurence of Spontaneous myocardial infarction Spontaneous myocardial infarction (MI) was defined as hospitalization for MI (ICD-10 codes I21 and I22) up to 5 years
Secondary Occurence of Repeat revascularization Repeat revascularization was defined as the presence of a procedure code after cancer surgery. up to 5 years
Secondary Occurence of Cancer recurrence Cancer recurrence was defined as the presence of chemotherapy and/or radiation therapy that began more than 6 months after surgery completion. up to 5 years
Secondary Occurence of All cause death Vital status was obtained from death certification collected by Statistics Korea at the Ministry of Strategy and Finance of South Korea. up to 5 years
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