early specialized cardiovascular intervention based on impedance cardiography in locally advanced non-small cell lung cancer patients

Conditions: Non-small Cell Lung Cancer; Cardiovascular Complication

Summary: this is a prospective, randomized, controlled, multi-center phase iii clinical trial that intends to evaluate the role of early cardiovascular intervention based on impedance cardiography in patients with locally advanced non-small cell lung cancer receiving radical radiochemotherapy±immunotherapy.

this is a prospective, randomized, controlled, multi-center phase iii clinical trial that intends to evaluate the role of early cardiovascular intervention based on impedance cardiography in patients with locally advanced non-small cell lung cancer receiving radical radiochemotherapy±immunotherapy. the participants were 1:1 randomized to the intervention group and the control group. the intervention group will receive cardiovascular evaluation and intervention at multiple timepoints throughout treatment and follow-up, while the control group will be under observation unless severe cardiovascular events happen. the evaluation and intervention timepoints include: before neoadjuvant therapy, before radiotherapy, mid-radiotherapy, 2 months after the completion of radiotherapy, every 6 months thereafter for up to 2 years post-radiotherapy.

Eligibility criteria:
inclusion criteria: 1. it is diagnosed as non-small cell lung cancer by pathological examination or cytological examination; it is assessed as locally advanced, unresectable stage iii non-small cell lung cancer by imaging; 2. plan to receive radical radiotherapy and chemotherapy ± immunotherapy; 3. male or female between 18 and 75 years old; 4. life expectancy ≥ 12 weeks; 5. the world health organization (who) ps score is 0 or 1; 6. organ and bone marrow function meet the following conditions: forced expiratory volume per second (fev1) ≥1000 ml; absolute neutrophil count ≥1.5×10\^9/l; platelets ≥100×10\^9/l; hemoglobin ≥90 g/l ; serum creatinine clearance calculated according to the cockcroft-gault formula ≥50 ml/min (cockcroft and gault 1976); serum bilirubin ≤1.5 times the upper limit of normal (uln); alanine aminotransferase and aspartate aminotransferase ≤2.5 times uln; 7. a signed informed consent form is required before proceeding with any step in the research; 8. there is an abnormality in the initial cardiac output index. exclusion criteria: 1. ps score 2-4; 2. organ function impairment: fev1 \ 1.5 times uln; alanine aminotransferase and aspartate aminotransferase\>2.5 times uln; 3. unstable angina or myocardial infarction occurred in the past month; 4. arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics; 5. active endocarditis; 6. symptomatic severe aortic stenosis; 7. heart failure that has not been controlled; 8. acute pulmonary embolism, pulmonary infarction or low thrombosis (artery or vein) formation; 9. suspected or confirmed aortic dissection; 10. uncontrolled bronchial asthma; 11. pulmonary edema; 12. fingertip blood oxygen saturation at rest ≤85%; 13. acute non-cardiopulmonary diseases (such as infection, renal failure, thyrotoxicosis, etc.) that may affect sports performance or aggravate due to exercise; 14. mental disorders make it impossible to cooperate. 15. patients for whom drug intervention is clearly recommended according to the 2022 edition of the european society of cardiology guidelines on cardio-oncology.

Keywords: non-small cell lung cancer cardiovascular intervention impedance cardiography cardiovascular event