Clinical trial NCT06702436: Invasive vs. Conservative Management in Cancer Patients With Non-ST Elevation MI (CAN-NSTEMI)"
Official title: Impact of Treatment Approaches on Mortality in Cancer Patients With Non-ST Elevation Myocardial Infarction: Invasive vs. Conservative Strategies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction
Keywords: Non-ST Elevated Myocardial Infarction
Malignancy
Mortality
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 12500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: hospital mortality
timeFrame: 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:
measure: Length of hospital stay:
timeFrame: From the date of hospital admission for NSTEMI until the occurrence of mortality, cardiovascular events, or hospital discharge, assessed up to 100 days.
measure: Re-hospitalization rate
timeFrame: The time frame for assessing re-hospitalization is from the date of hospital discharge to 100 days post-discharge
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Oncology Training and Research Hospital
Study officials:
affiliation: ankara oncology trainig and research hospital
name: Arif Timuroğlu
role: PRINCIPAL_INVESTIGATOR
affiliation: ankara oncology trainig and research hospital
name: İmran Ceren
role: PRINCIPAL_INVESTIGATOR
References: