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Completed

NCT Number: NCT06357000

Time From PCI to Cancer Surgery and Cardiovascular and Oncologic Outcomes

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cancer Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Occurence of Bleeding

    Time frame: up to 5 years

    Bleeding requiring transfusion was defined by the transfusion codes (X2021, X2022, X2031, X2032, X2091, X2092, X2111, X2112, X2131, X2132).

Secondary outcomes

  1. Occurence of Spontaneous myocardial infarction

    Time frame: up to 5 years

    Spontaneous myocardial infarction (MI) was defined as hospitalization for MI (ICD-10 codes I21 and I22)

  2. Occurence of Repeat revascularization

    Time frame: up to 5 years

    Repeat revascularization was defined as the presence of a procedure code after cancer surgery.

  3. Occurence of Cancer recurrence

    Time frame: up to 5 years

    Cancer recurrence was defined as the presence of chemotherapy and/or radiation therapy that began more than 6 months after surgery completion.

  4. Occurence of All cause death

    Time frame: up to 5 years

    Vital status was obtained from death certification collected by Statistics Korea at the Ministry of Strategy and Finance of South Korea.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2024
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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