Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04819698 |
| Other study ID # |
LZJ003 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 2021 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
March 2021 |
| Source |
Peking Union Medical College Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
