A Pragmatic Clinical Trial to Evaluate the Impact of Clinical Propranolol Strategies on Myocardial Injury After Non-cardiac Surgery (MINS) in Patients Undergoing Breast Cancer Surgery With Hypertension or Angina
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Myocardial Injury after Noncardiac Surgery (MINS)
研究概览
简要总结
This study aims to evaluate the impact of using propranolol, a non-selective beta-blocker, on preventing myocardial injury after non-cardiac surgery (MINS) in breast cancer patients who also have hypertension or angina. Stress from surgery and anesthesia can increase sympathetic activity and inflammation, which may lead to heart stress. This pragmatic clinical trial will compare patients who are prescribed propranolol as part of their routine care with those who are not. Researchers will analyze blood samples and surgical tissues collected during normal treatment to observe changes in heart health and the tumor microenvironment.
详细描述
Breast cancer is the most common malignancy among women in Korea. Perioperative stress and acute physiological stimuli from surgery and anesthesia increase catecholamine secretion, which can lead to Myocardial Injury after Non-cardiac Surgery (MINS). Propranolol is known to stabilize hemodynamic variability by inhibiting sympathetic surge and reducing myocardial oxygen consumption. Recent studies also suggest that beta-blockers may influence the tumor microenvironment (TME) by reducing inflammation and regulating immune cell composition.This prospective, randomized, open-label, single-center pragmatic clinical trial will enroll 100 female patients (aged 20-70) with stage I-III breast cancer and comorbid hypertension or angina. Participants will be randomized 1:1 into two groups:
- Propranolol Group: Patients receive propranolol for at least 14 days before surgery.
- Non-Propranolol Group: Patients receive usual care without propranolol.The primary objective is to compare the incidence of MINS based on high-sensitivity Troponin T (hs-TnT) levels measured postoperatively. Exploratory objectives include analyzing markers of inflammation (CRP, LDH), tumor proliferation (Ki-67), and tumor-infiltrating lymphocytes (TILs) using blood and tissue samples naturally obtained during the clinical process. Long-term follow-up will be conducted for up to 5 years to evaluate recurrence and survival outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 20 to 70 years.
- •Patients diagnosed with hypertension or angina who require medication.
- •Patients diagnosed with unilateral, resectable primary breast cancer (ICD-10: C50), Stage I-III.
- •ECOG performance status of 0-
- •Patients scheduled to receive standard postoperative treatment (including adjuvant radiotherapy
- •Patients who voluntarily decide to participate and sign the written informed consent form
排除标准
- •Patients with distant metastases.
- •Patients with active infectious diseases, autoimmune diseases (including specific rheumatic diseases), coagulation disorders, or cardiovascular diseases other than hypertension or angina pectoris.
- •Patients with clinically significant hepatic, hematologic, or renal dysfunction, defined as any of the following:
- •① ANC <1,500/mm3
- •Platelets <100,000/mm3
- •Hb <9 g/dL
- •AST and ALT > 2.5 x upper limit of normal (ULN) ⑤ Alkaline phosphatase > 2.5 x ULN ⑥ Total bilirubin > 1 x ULN ⑦ Serum creatinine >1.5 x ULN or estimated creatinine clearance < 60 mL/min (as calculated using the method standard for the institution)
- •Patients with moderate to severe asthma or chronic obstructive pulmonary disease (COPD).
- •Patients who are pregnant or breastfeeding at the time of enrollment.
- •Patients with a history of malignancy within the past 5 years.
- •Patients for whom data collection is considered difficult at the discretion of the investigator.
- •Patients who are unable to understand or complete study questionnaires.
- •Patients who have received β-blockers within 30 days prior to screening.
- •Patients with systolic blood pressure < 100 mmHg or heart rate < 55 beats per minute.
研究组 & 干预措施
Non-Propranolol Group (Usual Care)
Participants will receive standard clinical care for hypertension or angina without the use of Propranolol or other beta-blockers before surgery
干预措施: Usual Care (Other)
Propranolol Group
Participants with hypertension or angina undergoing breast cancer surgery will receive Propranolol (dosage based on clinical indication) for at least 14 days before surgery until the morning of the operation.
干预措施: propranolol (Drug)
结局指标
主要结局
Incidence of Myocardial Injury after Noncardiac Surgery (MINS)
时间窗: From the day of surgery (Day 0) up to 30 days postoperatively
MINS is defined as an elevated high-sensitivity cardiac Troponin T (hs-TnT) level measured for clinical purposes after surgery that exceeds the 99th percentile upper reference limit. Specifically, it is defined as: 1. 0.02-0.065 ng/mL with an absolute change of more than 0.005ng/mL or 2. any elevation ≥0.065 ng/mL or any absolute change more than 0.014 ng/mL
次要结局
- Perioperative Hemodynamic Stability: Systolic Blood Pressure Fluctuation(During surgery and in the recovery room (up to 2hours post-surgery)(Day 0))
- Perioperative Hemodynamic Stability: Heart rate Fluctuation(During surgery and in the recovery room (up to 2hours post-surgery)(Day 0))
- Postoperative Cardiovascular and Respiratory Complications Rate(Within 30 days after surgery)
- length of hospital stay(Within 30 days after surgery)
- Change in Patient-Reported Anxiety (HADS-A)(Baseline (Screening), Just before surgery (Day 0), and 6 months after surgery)
研究者
Chang-Ik Yoon
Assistant Professor, Seoul St. Mary's Hospital
Seoul St. Mary's Hospital