- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06884436
Preoperative Cardiology Consultation and the Incidence of Major Adverse Cardiac Events(MACE) (MACE)
The Relationship Between Preoperative Cardiology Consultation and the Incidence of Major Adverse Cardiac Events in Patients Without Cardiac Surgery--A Retrospective Cohort Study
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing, China
- Department of Anesthesiology, The First Medical Center, Chinese PLA General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 65 years;
- Preoperative ECG results available.
Exclusion Criteria:
- Age < 65 years;
- Accepted cardiac or neuro surgery;
- Second surgery within 30 days post-operation;
- Patient refused to follow up.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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MACE
Time Frame: within 30 days post-surgery
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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.
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within 30 days post-surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jingsheng Lou, PhD & MD, The First Medical Center, Chinese PLA General Hospital
Publications and helpful links
General 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.
- Smilowitz 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.
- Hao 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Vascular Diseases
- Pathologic Processes
- Heart Diseases
- Necrosis
- Myocardial Ischemia
- Ischemia
- Heart Arrest
- Chest Pain
- Angina Pectoris
- Cardiovascular Diseases
- Death, Sudden, Cardiac
- Death
- Myocardial Infarction
- Infarction
- Angina, Unstable
- Arrhythmias, Cardiac
- Death, Sudden
Other Study ID Numbers
- PLAGH-AOC-L05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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