Invasive vs. Conservative Management in Cancer Patients With Non-ST Elevation MI (CAN-NSTEMI)"

NCT06702436 | Completed

• 1 other identifier: NONST_MI_ONCOLOGY
• Study Type: observational
• Target: 12,500
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective study investigates the impact of invasive versus conservative management strategies in cancer patients presenting with non-ST elevation myocardial infarction (non-ST MI). Patients aged 18 and older, who were treated for non-ST MI in a hospital setting and had a confirmed cancer diagnosis, are included. The primary outcome is hospital mortality, assessed using GRACE scores to evaluate mortality risk. Patients are grouped based on their received interventions-either invasive (including coronary angiography and revascularization) or pharmacological treatment. Risk factors contributing to mortality, such as cancer type, metastasis presence, comorbidities, and laboratory findings, will also be analyzed to better understand the interplay of oncologic and cardiovascular conditions in this population.

Conditions

Myocardial Infarction

Keywords

Non-ST Elevated Myocardial Infarction; Malignancy; Mortality

Outcome Measures

Primary Outcomes (1)

• hospital mortality

  Hospital mortality rate in cancer patients with non-ST elevation myocardial infarction, comparing invasive and conservative treatment strategies

  From the date of hospital admission for NSTEMI until the occurrence of mortality, cardiovascular events, or hospital discharge, assessed up to 30 days.

Secondary Outcomes (2)

• Length of hospital stay:

  From the date of hospital admission for NSTEMI until the occurrence of mortality, cardiovascular events, or hospital discharge, assessed up to 100 days.

• Re-hospitalization rate

  The time frame for assessing re-hospitalization is from the date of hospital discharge to 100 days post-discharge

Study Arms (2)

Invasive Treatment Group

The Invasive Treatment Group will include cancer patients aged 18 and older diagnosed with non-ST elevation myocardial infarction (NSTEMI) who received an invasive treatment approach. This group will consist of patients who underwent coronary angiography followed by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). These patients may have various cancer types, with no restriction on the diagnosis, but must have been treated with invasive procedures for NSTEMI during their hospitalization. The cohort will be assessed for mortality, re-hospitalization rates, and cardiovascular events. The study will also evaluate factors such as cancer stage, metastasis, and comorbidities to understand the outcomes of invasive treatment in this population.

Other: Observational Study

Conservative Treatment Group

The Conservative Treatment Group will include cancer patients aged 18 and older diagnosed with NSTEMI and managed with medical treatment alone. This group will consist of patients who received pharmacological management (antiplatelet therapy, anticoagulants, beta-blockers, statins) without coronary angiography or revascularization. These patients may have different cancer types, and the study will focus on those treated conservatively during their hospital stay. Mortality, re-hospitalization, and cardiovascular events will be assessed. The analysis will also consider cancer type, disease stage, comorbidities, and pharmacological therapy's impact on long-term outcomes.

Other: Observational Study

Interventions

Observational Study OTHER

This study does not involve any active intervention. It is an observational study comparing the outcomes of invasive and conservative treatment strategies for non-ST elevation myocardial infarction (NSTEMI) in cancer patients. The treatments are based on the clinical decisions made by the attending physicians

Conservative Treatment Group; Invasive Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients aged 18 and older, diagnosed with cancer and hospitalized for non-ST elevation myocardial infarction (NSTEMI). Both males and females with various cancer types will be eligible, and the study will focus on those receiving either invasive or conservative treatment for NSTEMI. Patients with severe comorbidities, such as end-stage diseases or missing critical data, will be excluded. The study aims to assess the impact of invasive versus conservative treatment strategies on mortality, re-hospitalization, and cardiovascular events in this cohort, which is often underrepresented in clinical trials. This population will help understand optimal treatment approaches for cancer patients with NSTEMI.

You may qualify if:

• Age: Patients aged 18 years and older.
• Diagnosis: Patients with a confirmed cancer diagnosis.
• Acute Condition: Patients diagnosed with non-ST elevation myocardial infarction (non-ST MI).
• Treatment: Patients who received either invasive treatment (including coronary angiography and revascularization) or conservative (pharmacological) treatment for non-ST MI.
• Consent: Patients who have provided informed consent or are part of a retrospective study where consent is waived.

You may not qualify if:

• Age: Patients younger than 18 years.
• Non-cancer diagnoses: Patients without a cancer diagnosis.
• ST-Elevation Myocardial Infarction: Patients with ST elevation myocardial infarction (STEMI) instead of non-ST elevation myocardial infarction (NSTEMI).
• Pre-existing severe comorbidities: Patients with severe or terminal comorbidities (e.g., end-stage liver disease, end-stage renal disease, or severe cognitive impairment) that would confound the outcomes.
• Incomplete medical records: Patients with missing data on relevant clinical variables (e.g., GRACE score, treatment received, or mortality data).
• Pregnancy: Pregnant patients, as their conditions may complicate the interpretation of results.
• Inability to provide informed consent: Patients unable to provide informed consent (if applicable).

Sponsors & Collaborators

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: lead

Study Sites (1)

Ankara Oncology Training and Research Hospital

Ankara, Ankara, 06200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Arif Timuroğlu

  ankara oncology trainig and research hospital

  PRINCIPAL INVESTIGATOR

• İmran Ceren

  ankara oncology trainig and research hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 25, 2024
• Study Start: June 1, 2024
• Primary Completion: November 20, 2024
• Study Completion: April 1, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)