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临床试验/NCT05752773
NCT05752773招募中不适用

Risk Identification and Prediction of Myocardial Injury After Laparoscopic Pheochromocytoma/Paraganglioma Resection:A Ambispective Cohort Study.

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2023年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
700
试验地点
1
主要终点
Myocardial injury after laparoscopic PPGL resection

研究概览

简要总结

This observational study was conducted in patients undergoing elective laparoscopic pheochromocytoma/paraganglioma(PPGL) resection. It mainly answers the following two main questions:

  1. What are the risk factors for myocardial injury after laparoscopic PPGL resection?
  2. How to establish the myocardial injury prediction model of laparoscopic PPGL resection?

Participants were not required to perform additional research work other than the usual postoperative follow-up within 30 days after surgery. No control group was set in this study, and no additional clinical intervention was performed.

详细描述

MI-PPGL is a single-center observational ambispective cohort study.On the basis of retrospective study, the research team plans to build a structured database to investigate the incidence of myocardial injury in laparoscopic PPGL-resection, and further analyze myocardial injury related risk factors. In particular, timing data such as vital signs(blood pressure,heart rate)will be included to construct an efficient and robust myocardial injury prediction model. At the same time, a prospective cohort study is carried out to verify the model, so as to test the prediction ability of myocardial injury and reduce the incidence of myocardial injury.

The investigators expect to enroll 700 patients, including at least 550 patients retrospectively and 150 patients prospectively.In this study, the main endpoint events of the prediction model are binary outcome. Conservatively estimated according to the "10EPV" principle, that is, each predictive factor included in the model needs at least 10 positive outcome endpoint for estimation (10 events per variable). The investigators expected 5 to 8 predictors to be included in the model, and at least 80 positive events to be included. The incidence of perioperative myocardial injury is 12~20%, so the estimated sample size was at least 666 patients. Considering the absence of data or subject withdrawal from the study. so the investigators expected to include 700 patients, including at least 550 retrospectively and 150 prospectively.

STATA (version 15.0; Stata Corp., TX, USA) and R 3.6.1 software (R Foundation for Statistical Computing, Vienna, Austria) will be used for statistical analysis. Binary logistic regression was used to screen risk factors and stratify risk levels. P<0.05 was considered statistically significant. For predictive modeling, clinical databases were 9:1 or 8: 2. Randomly split into training samples and verification samples. In the training samples, optimal subset method and LASSO regression will be used for feature selection.Receiver operating characteristic curve (ROC curve) was used to represent the model differentiation, and Nomogram was used to represent the predictive factors of multiple logistic regression. In the verification samples, Hosmer-Lemeshow goodness of fit test was used to test the calibration degree of the model, and P>0.05 was the acceptable level of estimated fitting of the model. Decision curve analysis (DCA curve) was used to verify the clinical applicability.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for Laparoscopic PPGL resection

排除标准

  • Open or laparoscopic conversion to open PPGL resection was excluded
  • Cardiac paraganglioma was excluded
  • History of congenital heart disease or cardiac surgery was excluded
  • Patients with preoperative troponin/hypersensitive troponin elevation were excluded
  • Carotid body tumor and accessory ganglioma of jugular tympanum without endocrine function were excluded

结局指标

主要结局

Myocardial injury after laparoscopic PPGL resection

时间窗: 30days after surgery

Myocardial injury was defined as an elevated troponin I level exceeding the 99th percentile upper reference limit due to cardiac ischemic causes.

次要结局

  • Acute myocardial infarction(30days after surgery)
  • Nonfatal cardiac arrest(30days after surgery)
  • Congestive heart failure(30days after surgery)
  • New atrial fibrillation(30days after surgery)
  • Stroke(30days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lan Ling

Attending doctor

Peking Union Medical College Hospital

研究点 (1)

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