Major Adverse Cardiac EventsMACENCT06884436
Preoperative Cardiology Consultation and the Incidence of Major Adverse Cardiac Events（MACE）
An observational study of Major Adverse Cardiac Events and Acute Myocardial Infarction (AMI), run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This cohort study aims to determine when preoperative cardiology consultation is needed to reduce the incidence of major adverse cardiac events (MACE) in elderly patients undergoing non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Major Adverse Cardiac Events, Acute Myocardial Infarction (AMI), Cardiac Death, Sudden
- How many people
- 22,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 31 Dec 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Select elderly patients who underwent elective surgery at the First Medical Center of the PLA General Hospital from January 2015 to August 2019. All subjects will sign an informed consent form; patients who cannot sign the informed consent form will be provided with verbal informed consent.
Who may be able to join
- Age ≥ 65 years;
- Preoperative ECG results available.
Who cannot join
- Age < 65 years;
- Accepted cardiac or neuro surgery;
- Second surgery within 30 days post-operation;
- Patient refused to follow up.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, The First Medical Center, Chinese PLA General Hospital
Beijing
About this study
Official title: The Relationship Between Preoperative Cardiology Consultation and the Incidence of Major Adverse Cardiac Events in Patients Without Cardiac Surgery--A Retrospective Cohort Study
This cohort study aims to determine when preoperative cardiology consultation is needed to reduce the incidence of major adverse cardiac events (MACE) in elderly patients undergoing non-cardiac surgery. The study collected data on elderly patients with preoperative electrocardiogram (ECG) results who underwent non-cardiac surgery. It was conducted at the First Medical Center of the Chinese People's Liberation Army General Hospital from January 2015 to August 2019. MACE was defined as a composite event occurring within 30 days postoperatively, including acute myocardial infarction, unstable angina, heart failure, new-onset severe arrhythmias, non-fatal cardiac arrest, and cardiac death. Data were extracted using structured query language (SQL) and reviewed by three experienced clinicians. Preoperative cardiology consultation was considered as a mediating variable. By modeling, the confounding factors and risk factors for MACE were identified, and the impact of cardiology consultation as a mediating factor on the incidence of postoperative MACE was evaluated. Additionally, the study aimed to identify which categories of ECG findings necessitate cardiology consultation to reduce the incidence of adverse cardiac events, thereby optimizing the cardiology consultation process.
Read the detailed description
Background Preoperative electrocardiogram (ECG) is one of the important methods for perioperative assessment. It can reflect the patient's cardiac condition to a certain extent and indicate the potential risk of major adverse cardiac events (MACE). When a patient has an abnormal preoperative ECG, the standard medical procedure is to consult with a cardiologist to assess cardiac risk and adjust cardiac function, thereby reducing the incidence of adverse cardiac events. However, some studies suggest that cardiology consultation may delay surgery for elderly fracture patients and that consultation does not affect the prognosis of some abdominal surgery patients. Conversely, other studies indicate that cardiology consultation can reduce the incidence of adverse cardiac events in patients undergoing major vascular surgery. Additionally, when the patient has a normal ECG, cardiology consultation is usually not provided. Yet, elderly patients often have multiple chronic diseases, and a normal ECG does not completely rule out cardiac problems, which significantly increases the incidence of adverse cardiac events. Therefore, identifying risk factors to reduce the incidence of adverse cardiac events in elderly non-cardiac surgery patients is particularly important.
Objectives:
To investigate the circumstances in which preoperative cardiology consultation is needed to reduce the incidence rate of MACE.
Methods:
MACE was defined as the composite of acute myocardial infarction (MI), unstable angina, heart failure (HF), new-onset severe arrhythmia, nonfatal cardiac arrest, and cardiac death, occurring during or within 30 days following non-cardiac surgery. MACE cases were identified by reviewing medical records. Structured query language (SQL) was employed to extract relevant data elements, including postoperative biochemical tests, electrocardiograms (ECGs), coronary angiograms, postoperative progress notes, and consultation reports. Patients could experience multiple MACE events. Three experienced clinicians conducted independent evaluations of complications. Any discrepancies were resolved through discussion and consensus. This cohort study involved non-cardiac surgery patients from the First Medical Center of the Chinese PLA General Hospital, covering the period from January 2015 to August 2019. Preoperative cardiology consultation was considered as a mediating variable. By modeling, the confounding factors and risk factors for MACE were identified, and the impact of cardiology consultation as a mediating factor on the incidence of postoperative MACE was evaluated. Additionally, the study aimed to identify which categories of ECG findings necessitate cardiology consultation to reduce the incidence of adverse cardiac events, thereby optimizing the cardiology consultation process.
- Conditions
- Major Adverse Cardiac Events, Acute Myocardial Infarction (AMI), Cardiac Death, Sudden, Cardiac Arrest (CA), Arrhythmia, Cardiac, Heart Failure (HF)
- Keywords
- Cardiology Consultation, Major Adverse Cardiac Events, Preoperative, elderly, electrocardiogram
- Medical subject headings
- Cardiovascular Diseases, Death, Sudden, Cardiac, Heart Arrest, Arrhythmias, Cardiac, Heart Failure, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Risk Predictors of Major Adverse Cardiac Events | Identify risk factors through the incidence of major adverse cardiac events occurring within 30 days post-surgery, and analyze the benefits to patients through the intervention of cardiology consultations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
The entire sample was divided into a development cohort and a validation cohort in a 7:3 ratio. Univariate and multivariate logistic regression analyses were conducted to identify risk predictors of MACE and to establish a nomogram with statistically significant predictors. The development cohort was used to construct the MACE prediction model, while the data from the validation cohort were used for validation. Preoperative cardiology consultation was considered as a mediating variable. By modeling, the confounding factors and risk factors for MACE were identified, and the impact of cardiology consultation as a mediating factor on the incidence of postoperative MACE was evaluated.
Measured: within 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Jan 2015
- Primary completion31 Aug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Adverse Cardiac EventsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Retrospective
- Enrolment
- 22,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingsheng Lou, Chinese PLA General Hospital
- Investigators
- Jingsheng Lou, PhD & MD, Principal investigator, The First Medical Center, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884436
- Sponsor's protocol ID
- PLAGH-AOC-L05
- Acronym
- MACE
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the sensitive nature of the questions posed in this study, we assured participants that their raw data would remain confidential. Therefore, the raw numerical data used to extrapolate the graphs/charts are not present within the manuscript and will not be disclosed. These data will be shared upon reasonable request made to the corresponding author.
Publications
Beattie WS, Lalu M, Bocock M, Feng S, Wijeysundera DN, Nagele P, Fleisher LA, Kurz A, Biccard B, Leslie K, Howell S, Landoni G, Grocott H, Lamy A, Richards T, Myles P; StEP COMPAC Group; Patient Comfort; Clinical Indicators; Delirium Postoperative Cognitive Dysfunction Stroke; Cardiovascular; Data Extractors; Respiratory; Inflammation Sepsis; Acute Kidney Injury; Bleeding Complications Patient Blood Management; Healthcare Resource Utilisation; Patient-Centred Outcomes; Organ Failure and Survival; Cancer Surgery. Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative: cardiovascular outcomes. Br J Anaesth. 2021 Jan;126(1):56-66. doi: 10.1016/j.bja.2020.09.023. Epub 2020 Oct 20.
PubMed 33092804Smilowitz NR, Berger JS. Perioperative Cardiovascular Risk Assessment and Management for Noncardiac Surgery: A Review. JAMA. 2020 Jul 21;324(3):279-290. doi: 10.1001/jama.2020.7840.
PubMed 32692391Hao L, Xu X, Dupre ME, Guo A, Zhang X, Qiu L, Zhao Y, Gu D. Adequate access to healthcare and added life expectancy among older adults in China. BMC Geriatr. 2020 Apr 9;20(1):129. doi: 10.1186/s12877-020-01524-9.
PubMed 32272883
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Preoperative Cardiology Consultation and the Incidence of Major Adverse Cardiac Events in Patients Without Cardiac Surgery--A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06884436
- Acronym / sponsor ID
- MACE / PLAGH-AOC-L05
- Conditions
- Major Adverse Cardiac Events, Acute Myocardial Infarction (AMI), Cardiac Death, Sudden, Cardiac Arrest (CA), Arrhythmia, Cardiac, Heart Failure (HF)
- Keywords
- Cardiology Consultation, Major Adverse Cardiac Events, Preoperative, elderly, electrocardiogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22,000 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Mar 2025 (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 cohort study aims to determine when preoperative cardiology consultation is needed to reduce the incidence of major adverse cardiac events (MACE) in elderly patients undergoing non-cardiac surgery. The study collected data on elderly patients with preoperative electrocardiogram (ECG) results who underwent non-cardiac surgery. It was conducted at the First Medical Center of the Chinese People's Liberation Army General Hospital from January 2015 to August 2019. MACE was defined as a composite event occurring within 30 days postoperatively, including acute myocardial infarction, unstable angina, heart failure, new-onset severe arrhythmias, non-fatal cardiac arrest, and cardiac death. Data were extracted using structured query language (SQL) and reviewed by three experienced clinicians. Preoperative cardiology consultation was considered as a mediating variable. By modeling, the confounding factors and risk factors for MACE were identified, and the impact of cardiology consultation as a mediating factor on the incidence of postoperative MACE was evaluated. Additionally, the study aimed to identify which categories of ECG findings necessitate cardiology consultation to reduce the incidence of adverse cardiac events, thereby optimizing the cardiology consultation process.
Detailed description
Background Preoperative electrocardiogram (ECG) is one of the important methods for perioperative assessment. It can reflect the patient's cardiac condition to a certain extent and indicate the potential risk of major adverse cardiac events (MACE). When a patient has an abnormal preoperative ECG, the standard medical procedure is to consult with a cardiologist to assess cardiac risk and adjust cardiac function, thereby reducing the incidence of adverse cardiac events. However, some studies suggest that cardiology consultation may delay surgery for elderly fracture patients and that consultation does not affect the prognosis of some abdominal surgery patients. Conversely, other studies indicate that cardiology consultation can reduce the incidence of adverse cardiac events in patients undergoing major vascular surgery. Additionally, when the patient has a normal ECG, cardiology consultation is usually not provided. Yet, elderly patients often have multiple chronic diseases, and a normal ECG does not completely rule out cardiac problems, which significantly increases the incidence of adverse cardiac events. Therefore, identifying risk factors to reduce the incidence of adverse cardiac events in elderly non-cardiac surgery patients is particularly important.
Objectives:
To investigate the circumstances in which preoperative cardiology consultation is needed to reduce the incidence rate of MACE.
Methods:
MACE was defined as the composite of acute myocardial infarction (MI), unstable angina, heart failure (HF), new-onset severe arrhythmia, nonfatal cardiac arrest, and cardiac death, occurring during or within 30 days following non-cardiac surgery. MACE cases were identified by reviewing medical records. Structured query language (SQL) was employed to extract relevant data elements, including postoperative biochemical tests, electrocardiograms (ECGs), coronary angiograms, postoperative progress notes, and consultation reports. Patients could experience multiple MACE events. Three experienced clinicians conducted independent evaluations of complications. Any discrepancies were resolved through discussion and consensus. This cohort study involved non-cardiac surgery patients from the First Medical Center of the Chinese PLA General Hospital, covering the period from January 2015 to August 2019. Preoperative cardiology consultation was considered as a mediating variable. By modeling, the confounding factors and risk factors for MACE were identified, and the impact of cardiology consultation as a mediating factor on the incidence of postoperative MACE was evaluated. Additionally, the study aimed to identify which categories of ECG findings necessitate cardiology consultation to reduce the incidence of adverse cardiac events, thereby optimizing the cardiology consultation process.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risk Predictors of Major Adverse Cardiac Events | – | –Identify risk factors through the incidence of major adverse cardiac events occurring within 30 days post-surgery, and analyze the benefits to patients through the intervention of cardiology consultations. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Select elderly patients who underwent elective surgery at the First Medical Center of the PLA General Hospital from January 2015 to August 2019. All subjects will sign an informed consent form; patients who cannot sign the informed consent form will be provided with verbal informed consent.
Key inclusion criteria (2 listed)
- Age ≥ 65 years;
- Preoperative ECG results available.
Key exclusion criteria (4 listed)
- Age < 65 years;
- Accepted cardiac or neuro surgery;
- Second surgery within 30 days post-operation;
- Patient refused to follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACE
Time frame: within 30 days post-surgery
The entire sample was divided into a development cohort and a validation cohort in a 7:3 ratio. Univariate and multivariate logistic regression analyses were conducted to identify risk predictors of MACE and to establish a nomogram with statistically significant predictors. The development cohort was used to construct the MACE prediction model, while the data from the validation cohort were used for validation. Preoperative cardiology consultation was considered as a mediating variable. By modeling, the confounding factors and risk factors for MACE were identified, and the impact of cardiology consultation as a mediating factor on the incidence of postoperative MACE was evaluated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Results publication: PubMed 33092804Beattie WS, Lalu M, Bocock M, Feng S, Wijeysundera DN, Nagele P, Fleisher LA, Kurz A, Biccard B, Leslie K, Howell S, Landoni G, Grocott H, Lamy A, Richards T, Myles P; StEP COMPAC Group; Patient Comfort; Clinical Indicators; Delirium Postoperative Cognitive Dysfunction Stroke; Cardiovascular; Data Extractors; Respiratory; Inflammation Sepsis; Acute Kidney Injury; Bleeding Complications Patient Blood Management; Healthcare Resource Utilisation; Patient-Centred Outcomes; Organ Failure and Survival; Cancer Surgery. Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative: cardiovascular outcomes. Br J Anaesth. 2021 Jan;126(1):56-66. doi: 10.1016/j.bja.2020.09.023. Epub 2020 Oct 20.
- Results publication: PubMed 32692391Smilowitz NR, Berger JS. Perioperative Cardiovascular Risk Assessment and Management for Noncardiac Surgery: A Review. JAMA. 2020 Jul 21;324(3):279-290. doi: 10.1001/jama.2020.7840.
- Results publication: PubMed 32272883Hao L, Xu X, Dupre ME, Guo A, Zhang X, Qiu L, Zhao Y, Gu D. Adequate access to healthcare and added life expectancy among older adults in China. BMC Geriatr. 2020 Apr 9;20(1):129. doi: 10.1186/s12877-020-01524-9.
- Individual participant dataSharing planned: No. Given the sensitive nature of the questions posed in this study, we assured participants that their raw data would remain confidential. Therefore, the raw numerical data used to extrapolate the graphs/charts are not present within the manuscript and will not be disclosed. These data will be shared upon reasonable request made to the corresponding author.
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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.
Jingsheng Lou, PhD & MD principal investigator
The First Medical Center, Chinese PLA General Hospital
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 Major Adverse Cardiac Events and Acute Myocardial Infarction (AMI), run by Chinese PLA General 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: finished, as of the sponsor's last update on 28 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: within 30 days post-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 NCT06884436, which also lists 3 linked publications.
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 28 Mar 2025.