Coronary Artery DiseaseNCT06357000
Time From PCI to Cancer Surgery and Cardiovascular and Oncologic Outcomes
An observational study of Coronary Artery Disease and Cancer, run by Samsung Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Cancer
- How many people
- 3,621 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Early-stage cancer patients who underwent PCI before the cancer surgery.
Who may be able to join
- 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
Who cannot join
- participants who received neoadjuvant or adjuvant treatment for cancer
About this study
Official title: Association Between 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.
Read the detailed 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.
- Conditions
- Coronary Artery Disease, Cancer
- Keywords
- Time, Percutaneous coronary intervention, Cancer surgery
- Medical subject headings
- Coronary Artery Disease, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Time between the dates of PCI and cancer surgery <12 months | Time between the dates of PCI and cancer surgery <12 months | |
| time between the dates of PCI and cancer surgery ≥12 months | time between the dates of PCI and cancer surgery ≥12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Bleeding
Bleeding requiring transfusion was defined by the transfusion codes (X2021, X2022, X2031, X2032, X2091, X2092, X2111, X2112, X2131, X2132).
Measured: up to 5 years
Secondary outcomes (4)
Occurence of Spontaneous myocardial infarction
Spontaneous myocardial infarction (MI) was defined as hospitalization for MI (ICD-10 codes I21 and I22)
Measured: up to 5 years
Occurence of Repeat revascularization
Repeat revascularization was defined as the presence of a procedure code after cancer surgery.
Measured: up to 5 years
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.
Measured: up to 5 years
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.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Jan 2008
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,621 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hong Choi, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357000
- Sponsor's protocol ID
- Time from PCI to surgery
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi KH, Lee J, Lee J, Cho J, Kang D, Kim HK. Association Between Time From Percutaneous Coronary Intervention to Cancer Surgery and Cardiovascular and Oncological Outcomes. J Am Heart Assoc. 2025 May 6;14(9):e038569. doi: 10.1161/JAHA.124.038569. Epub 2025 Apr 16.
PubMed 40240888
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Time From PCI to Cancer Surgery and Cardiovascular and Oncologic Outcomes
- ClinicalTrials.gov ID
- NCT06357000
- Acronym / sponsor ID
- Time from PCI to surgery
- Conditions
- Coronary Artery Disease, Cancer
- Keywords
- Time, Percutaneous coronary intervention, Cancer surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,621 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time between the dates of PCI and cancer surgery <12 months | – | –Time between the dates of PCI and cancer surgery <12 months |
| time between the dates of PCI and cancer surgery ≥12 months | – | –time between the dates of PCI and cancer surgery ≥12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Early-stage cancer patients who underwent PCI before the cancer surgery.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- participants who received neoadjuvant or adjuvant treatment for cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
4 secondary outcomes
Occurence of Spontaneous myocardial infarction
Time frame: up to 5 years
Occurence of Repeat revascularization
Time frame: up to 5 years
Occurence of Cancer recurrence
Time frame: up to 5 years
Occurence of All cause death
Time frame: up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 40240888Choi KH, Lee J, Lee J, Cho J, Kang D, Kim HK. Association Between Time From Percutaneous Coronary Intervention to Cancer Surgery and Cardiovascular and Oncological Outcomes. J Am Heart Assoc. 2025 May 6;14(9):e038569. doi: 10.1161/JAHA.124.038569. Epub 2025 Apr 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Cancer, run by Samsung Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of Bleeding (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06357000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.