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Perioperative Cardiac Complications in Noncardiac Surgery in Tibet, China

2021年3月26日 更新者:Peking Union Medical College Hospital

Evaluation of Perioperative Cardiac Complications in Noncardiac Surgery in Tibet Autonomous Region in China:the Incidence, Risk Factors and Cardiac Troponin Monitoring

This observational study will describe the incidence and risk factors of perioperative cardiac complications (PCCs) in patients undergoing non-cardiac surgery in Tibet Autonomous Region. And perioperative troponin monitoring will be implemented in these population.

調査の概要

詳細な説明

Background: Worldwide, more than 300 million major noncardiac surgeries are performed every year and the number is increasing continuously. Perioperative cardiac complications (PCCs) are the first causes of morbidity and mortality within 30 days after noncardiac surgery which result in prolonged length of stay, increased health care costs and poorer prognosis. Several preoperative factors such as advanced age, obesity, coronary artery disease, heart failure (HF), cerebrovascular disease, diabetes mellitus, and renal dysfunction has been confirmed strongly associated with PCCs, as well as some intraoperative factors (hypotension and hypoxemia), and postoperative factors (pain and bleeding). And more than 3% patients undergoing noncardiac surgery are estimated to suffer a myocardial injury after noncardiac surgery (MINS), defined as elevated postoperative troponin measurement without the requirement of an ischemic feature. Many of the patients with MINS does not fulfill the conventional clinical diagnosis of myocardial infarction (e.g., ischemic symptom, ischemic electrocardiography finding). However, the prognosis of MINS is very poor. Therefore, cardiac troponin levels need to be monitored in high-risk patients to avoid misdiagnosis and taking the opportunity of secondary prophylactic measures and following-up.

Tibet Autonomous Region in China is located in a low-oxygen, low-pressure area, with the average altitude of more than 4000 meters. Polycythemia and hyperlipemia are common in native patients there, with increased prostaglandin, faster basal heart rate, higher blood pressure and higher myocardial oxygen consumption and restricted cardiac reserve function comparing to patients from plains areas. The mismatch between oxygen supply and demand could aggravate in the perioperative period, which is the prominent pathogenesis on PCCs. Accordingly, the risk of PCCs may rise remarkably in the high-altitude and hypoxia region. Not only that, the incidence characteristics and risk factors of PCCs in noncardiac surgery could be also partially different from those in flat area in China. However, the relevant data are currently blank.

Aim: To evaluate the incidence of PCCs, the risk indicators and the value of cardiac troponin monitoring for patients undergoing noncardiac surgery in Tibet Autonomous Region in China, allowing a better assessment and optimizing of the patients there.

Methodology: The study consists of two sub studies. Sub study A: Risk factors of PCCs in patients undergoing non-cardiac surgery in Tibet Autonomous Region. Sub study B: Implement perioperative cardiac troponin I (cTnI) monitoring.

Study A: 600 patients over 50 years old undergoing elective major noncardiac surgery in Tibet Autonomous Region People's Hospital will be included and followed for 30 days after surgery for the occurrence of PCCs and other major adverse events. Patients will receive a standardized evaluation, including preoperative historical, laboratory, and physiologic assessment. Perioperative information will also be collected, including type of surgery, anesthetic management, intraoperative transfusion, postoperative complications, etc. PCCs are defined as acute coronary syndrome (ACS), HF, new-onset severe arrhythmia, nonfatal cardiac arrest, and cardiac death.

Study B: 100 patients over 50 years old undergoing major noncardiac surgery in Tibet Autonomous Region People's Hospital will be included. Clinical data including demographics, preoperative evaluation, surgical invasiveness, ASA grade, anesthetic management, and other relevant perioperative information. The investigators will measure cTnI at baseline prior to surgery, as well as on 1h,12h, 24h and 72h after surgery for each patient. MINS will be defined if a rise of cTnI with an absolute value above the 99th percentile upper reference is detected, and then a clinical evaluation, 12-lead ECG and even coronary angiography (if needed) will be performed to adjudicate the occurrence of PCCs. The incident of MINS and the value of cTnI monitoring for early diagnosis of PCCs will be assessed for patients undergoing noncardiac surgery in Tibet Autonomous Region.

Potential Significance: This study will generate major scientific implications by contributing to closing current knowledge gaps concerning the incidence and risk factors of PCCs, as well as the value of cTnI monitoring for patients undergoing noncardiac surgery in Tibet Autonomous Region. This knowledge will have important clinical implications in the high-attitude area leading to a better optimization of the perioperative management.

研究の種類

観察的

入学 (予想される)

700

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Beijing、中国
        • Peking Union Medical College Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

50年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

Patients aged 50 years or older undergoing intermediate to high-risk elective noncardiac surgery.

説明

Inclusion Criteria:

  • Patients aged 50 years or older;
  • Undergoing intermediate to high-risk elective noncardiac surgery .

Exclusion Criteria:

  • Emergency surgery;
  • Local anesthesia;
  • Low-risk surgery;
  • ASA classification V or VI

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Perioperative cardiac complications
時間枠:Participants will be followed for 30 days after surgery
Perioperative cardiac complications are defined as acute coronary syndrome (ACS), heart failure, new-onset severe arrhythmia, nonfatal cardiac arrest, and cardiac death. ACS included ST-elevation myocardial infarction (STEMI) and non-ST-elevation acute coronary syndrome (NSTE-ACS). NSTE-ACS could be further subdivided into non-ST-elevation myocardial infarction and unstable angina according to the cardiac biomarkers.
Participants will be followed for 30 days after surgery

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2021年4月1日

一次修了 (予想される)

2022年8月1日

研究の完了 (予想される)

2022年12月1日

試験登録日

最初に提出

2021年3月24日

QC基準を満たした最初の提出物

2021年3月26日

最初の投稿 (実際)

2021年3月29日

学習記録の更新

投稿された最後の更新 (実際)

2021年3月29日

QC基準を満たした最後の更新が送信されました

2021年3月26日

最終確認日

2021年3月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • LZJ003

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はい

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