Time From PCI to Cancer Surgery and Cardiovascular and Oncologic Outcomes

Cancer Clinical Trial

Official title:

Association Between Time From PCI to Cancer Surgery and Cardiovascular and Oncologic Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06357000
• Other study ID #: Time from PCI to surgery
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cancer
• Coronary Artery Disease

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