Perioperative assessment and management of cardiovascular risk in patients undergoing noncardiac surgery who under the care of surgical and medical co-management.
| ISRCTN | ISRCTN58897355 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58897355 |
- Submission date
- 16/12/2023
- Registration date
- 19/12/2023
- Last edited
- 17/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aim
Perioperative myocardial injury/infarction (PMI) following noncardiac surgery has been increasingly recognized as a frequent cardiac complication, which occurs in at least 8% of elective procedures, and 20% of major surgeries. Moreover, PMI is independently associated with an increased risk of cardiovascular (CV) morbidity and mortality at 30 days and up to 1 year after noncardiac surgery. The practice of surgical and medical co-management (SMC) is gaining popularity, as there has been a rapid increase in the percentage of noncardiac surgical patients under SMC, mainly in the United States. However, little is known about the incidence, predictors, or impact of PMI on 30-day mortality in intermediate- or high-risk noncardiac surgery patients under the care of the SMC model in a real-world clinical setting. The study team is a perioperative SMC team with 35 years of clinical experience in perioperative management. This study aims to evaluate the incidence, risk, and impact of PMI in patients at increased CV risk who underwent intermediate- or high-risk noncardiac surgery under the SMC model.
Who can participate?
Patients aged ≥ 65 years old, or ≥ 50 years old with a history of cardiovascular disease (CVD) or CV risk factors (e.g., smoking, obesity, hypertension, diabetes, and dyslipidemia), and treated with intermediate- or high-risk noncardiac surgery and with a postoperative stay of ≥ 2 days during hospitalization in our department between January 2017 and December 2022.
What does the study involve?
Patients can voluntarily participate in this study if they are fully aware of our study. All patients were routinely treated at the discretion of the SMC team during hospitalization, following the updated clinical guidelines without other intervention. The SMC model was initiated when surgical intervention was indicated and throughout the entire perioperative period. The incidence, risk factors, and impact of PMI on 30-day mortality were analyzed. The ability of the Revised Cardiac Risk Index (RCRI), frailty, and their combination to predict PMI was evaluated.
What are the possible benefits and risks of participating?
Patients’ perioperative condition will be better monitored and guided if they are participating in this study. This study does not involve specific study drugs, and there are no prescription requirements. Based on the study itself, it will not bring any risk or adverse reactions for patients.
Where is the study run from?
Second Medical Center, Chinese PLA General Hospital (China)
When is the study starting and how long is it expected to run for?
January 2016 to December 2023.
Who is funding the study?
National Clinical Research Center for Geriatric Diseases (China)
Who is the main contact?
Dr. Xi, xishaozhi@163.com
Contact information
Principal Investigator
No. 28 Fu Xing Road
Beijing
100853
China
| Phone | +8615801612879 |
|---|---|
| gaolinggen@163.com |
Public, Scientific
No. 28 Fu Xing Road
Beijing
100853
China
| Phone | +8615724715289 |
|---|---|
| xishaozhi@163.com |
Study information
| Study design | Single-center prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Prevention, Screening, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Perioperative cardiovascular risk assessment and management after intermediate- or high-risk noncardiac surgery in patients under surgical and medical co-management. |
| Study objectives | This study evaluated the incidence, risk, and impact of perioperative myocardial injury/infarction (PMI) in patients at increased cardiovascular (CV) risk who underwent intermediate- or high-risk noncardiac surgery under the surgical and medical co-management (SMC) model. |
| Ethics approval(s) |
Approved 03/11/2016, Ethics Committee of Chinese PLA General Hospital (No. 28 Fu Xing Road, Beijing, 100853, China; +86 10 6693 7166; jfjzyygw@163.com), ref: S2023-555-01 |
| Health condition(s) or problem(s) studied | Perioperative cardiovascular risk after intermediate- or high-risk noncardiac surgery. |
| Intervention | Patients who are at increased cardiovascular risk when undergoing intermediate- or high-risk noncardiac surgery during hospitalization will be recruited. All patients will be routinely treated with perioperative management by the surgical and medical co-management (SMC) team. The SMC model is initiated when a surgical intervention is indicated and throughout the entire perioperative period. The incidence, risk factors, and impact of perioperative myocardial injury/infarction (PMI) on 30-day mortality will be analyzed. |
| Intervention type | Other |
| Primary outcome measure | Impact of perioperative myocardial injury/infarction (PMI) on 30-day mortality measured using patient medical records at one time point |
| Secondary outcome measures | Postoperative complications measured using patient medical records at one time point include: 1. Acute coronary syndrome (ACS) 2. The Clavien-Dindo classification of surgical complications 3. 30-day mortality |
| Overall study start date | 01/01/2016 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 50 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 600 |
| Total final enrolment | 623 |
| Key inclusion criteria | 1. ≥ 65 years old, or ≥ 50 years old with a history of cardiovascular disease (CVD) or CV risk factors (e.g., smoking, obesity, hypertension, diabetes, and dyslipidemia). 2. Treated with intermediate- or high-risk noncardiac surgery according to the criteria of the ESC/ESA surgical risk score and with a postoperative stay of ≥ 2 days. |
| Key exclusion criteria | Patients were excluded if one of the following was met: 1. Cardiac surgery or MI within 14 days before admission 2. Surgery involving a cardiac surgeon 3. Low-risk noncardiac surgery 4. No cTn measurement within 14 days before surgery or 3 days after surgery 5. Elevated preoperative cTn level 6. Lost to follow-up after discharge |
| Date of first enrolment | 01/01/2017 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Beijing
100853
China
Sponsor information
Hospital/treatment centre
No. 28 Fu Xing Road
Bei
100853
China
| Phone | +86-010-66876224 |
|---|---|
| jfjzyygw@163.com | |
| Website | http://www.301hospital.com.cn/en2012/web/Introduction.html |
"ROR" |
https://ror.org/04gw3ra78 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal within 1 or 2 years of the end of the overall study |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from Dr. Xi, xishaozhi@163.com. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 21/06/2024 | 17/01/2025 | Yes | No |
Editorial Notes
17/01/2025: Publication reference added.
19/12/2023. Study's existence confirmed by the Ethics Committee of Chinese PLA General Hospital (China).
