Perioperative Cardiac ComplicationsNCT04819698
Perioperative Cardiac Complications in Noncardiac Surgery in Tibet, China
An observational study of Perioperative Cardiac Complications, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Perioperative Cardiac Complications
- What is being tested?
- Troponin I (cTnI ) monitoring
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- Apr 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 50 years or older undergoing intermediate to high-risk elective noncardiac surgery.
Who may be able to join
- Patients aged 50 years or older;
- Undergoing intermediate to high-risk elective noncardiac surgery .
Who cannot join
- Emergency surgery;
- Local anesthesia;
- Low-risk surgery;
- ASA classification V or VI
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing
Yuguang Huang, M.D., 86-10-69152020, garypumch@163.com
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Perioperative Cardiac Complications
- Being tested
- Troponin I (cTnI ) monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Troponin I (cTnI ) monitoringOther
cTnI will be measured at baseline prior to surgery, as well as on 1h,12h, 24h and 72h after surgery for each patient in study B.
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative cardiac complications
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.
Measured: Participants will be followed for 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study startApr 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative Cardiac ComplicationsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tibet Autonomous Region People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819698
- Sponsor's protocol ID
- LZJ003
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zhu Q, Duan H, Liu Z, Li Y, Zhang Y, Labaciren, Shen L, Huang Y. The incidence and risk factors of perioperative cardiac complications in noncardiac major surgery in high-altitude areas: A prospective trial in Tibet autonomous region, China. Front Cardiovasc Med. 2023 Apr 3;10:1158711. doi: 10.3389/fcvm.2023.1158711. eCollection 2023.
PubMed 37077733
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perioperative Cardiac Complications in Noncardiac Surgery in Tibet Autonomous Region in China:the Incidence, Risk Factors and Cardiac Troponin Monitoring
- ClinicalTrials.gov ID
- NCT04819698
- Acronym / sponsor ID
- LZJ003
- Conditions
- Perioperative Cardiac Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Tibet Autonomous Region People's Hospital
- Study start
- Apr 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 50 years or older undergoing intermediate to high-risk elective noncardiac surgery.
Key inclusion criteria (2 listed)
- Patients aged 50 years or older;
- Undergoing intermediate to high-risk elective noncardiac surgery .
Key exclusion criteria (4 listed)
- Emergency surgery;
- Local anesthesia;
- Low-risk surgery;
- ASA classification V or VI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Troponin I (cTnI ) monitoringcTnI will be measured at baseline prior to surgery, as well as on 1h,12h, 24h and 72h after surgery for each patient in study B. | Other | – |
Primary outcome
Perioperative cardiac complications
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Derived from this study: PubMed 37077733Zhu Q, Duan H, Liu Z, Li Y, Zhang Y, Labaciren, Shen L, Huang Y. The incidence and risk factors of perioperative cardiac complications in noncardiac major surgery in high-altitude areas: A prospective trial in Tibet autonomous region, China. Front Cardiovasc Med. 2023 Apr 3;10:1158711. doi: 10.3389/fcvm.2023.1158711. eCollection 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Cardiac Complications, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative cardiac complications (time frame: Participants will be followed for 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04819698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.