Major Adverse Cardiac EventsNCT06391632
Construction of a Prediction Model for MACCE in Elderly Patients After Elective Non-cardiac Surgery
An observational study of Major Adverse Cardiac Events and Cerebrovascular Accident, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
Severe cardiovascular and cerebrovascular complications, including cardiac death, non-fatal angina/myocardial infarction, non-fatal heart failure, stroke, severe arrhythmia, etc., are one of the main types of postoperative complications in elderly patients, and are also the main causes of perioperative death in… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Major Adverse Cardiac Events, Cerebrovascular Accident, Postoperative Complications
- What is being tested?
- Revised Cardiac Risk Index
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Mar 2025
- 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: Patients over 65 years of age undergoing elective non-cardiac surgery
Who may be able to join
- The subjects were patients with elective non-cardiac surgery;
- Older than 65 years;
- Patients signed informed consent.
Who cannot join
- The anesthesia should be received in any of the following ways: local anesthesia;
- local anesthesia enhancement, and simple nerve block anesthesia;
- Patients who are scheduled to undergo day surgery;
- Expected operation time <1 hour for patients;
- Patients who are expected to stay in hospital for less than 3 days after surgery;
- Patients who refuse to enroll.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, 1000000
Yin MD, HaoIin, 374916066@qq.com
About this study
Official title: Construction of a Prediction Model for Severe Cardiovascular and Cerebrovascular Complications in Elderly Patients After Elective Non-cardiac Surgery: a Prospective Cohort Study
Severe cardiovascular and cerebrovascular complications, including cardiac death, non-fatal angina/myocardial infarction, non-fatal heart failure, stroke, severe arrhythmia, etc., are one of the main types of postoperative complications in elderly patients, and are also the main causes of perioperative death in elderly patients. With the aging population and the large proportion of elderly patients undergoing non-cardiac surgery, it is increasingly important to establish a prediction model for postoperative severe cardiovascular and cerebrovascular events in elderly patients undergoing noncardiac surgery.
Read the detailed description
This project intends to use a multi-center, prospective cohort study method to include about 3000 elderly patients over 65 years old who are planning to undergo non-cardiac surgery, collect relevant data before, during and after surgery, observe the occurrence of serious cardiovascular and cerebrovascular complications in the perioperative period, establish a "MACCE risk prediction model for elderly patients after elective non-cardiac surgery", and verify its effectiveness and reliability. The results of this study will help to improve the predictive ability of postoperative complications of severe cardiovascular and cerebrovascular events in elderly patients undergoing elective non-cardiac surgery, which is conducive to early risk assessment, risk classification, strengthening perioperative patient management, reducing the incidence of postoperative MACCE, and improving the prognosis of elderly patients.
- Conditions
- Major Adverse Cardiac Events, Cerebrovascular Accident, Postoperative Complications, Models
- Being tested
- Revised Cardiac Risk Index
- Keywords
- Elderly patients, Elective non-cardiac surgery, MACCEs, Postoperative Complications, Selective Operation, predictive model
- Medical subject headings
- Cardiovascular Diseases, Stroke, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revised Cardiac Risk IndexDiagnostic test
Also called Frailty index scale, The Quality of Recovery-15 scale
The Revised Cardiac Risk Index (RCRI) attempts to estimate the likelihood of cardiac complications during hospitalization in patients undergoing noncardiac surgery.The Frailty Index is a commonly used tool in clinical practice to assess the degree of frailty in patients.The Quality of Recovery-15 scale (QoR-15) is an easy-to-use score for assessing the quality of post-operative recovery.
| Study group | Role | What they receive |
|---|---|---|
| positive event group | The following complications occur within 3-7 days after surgery：
1. all-cause death;
2. non-fatal myocardial infarction/angina pectoris (new or recurring);
3. non-fatal heart failure (new onset or recurrence);
4. non-fatal cerebral infarction (new or reappeared);
5. new or recurrent malignant arrhythmias (ventricular tachycardia/ventricular fibrillation, atrial flutter/atrial fibrillation, hemodynamically unstable second/third degree atrioventricular block); Receives: Diagnostic Test: Revised Cardiac Risk Index | |
| negative event group | The following complications did not occur within 3-7 days after surgery：
1. all-cause death;
2. non-fatal myocardial infarction/angina pectoris (new or recurring);
3. non-fatal heart failure (new onset or recurrence);
4. non-fatal cerebral infarction (new or reappeared);
5. new or recurrent malignant arrhythmias (ventricular tachycardia/ventricular fibrillation, atrial flutter/atrial fibrillation, hemodynamically unstable second/third degree atrioventricular block); Receives: Diagnostic Test: Revised Cardiac Risk Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac and Cerebrovascular event（MACCE）occurred in elderly patients after elective non-cardiac surgery
- all-cause death;
- non-fatal myocardial infarction/angina pectoris (new or recurring);
- non-fatal heart failure (new onset or recurrence);
- non-fatal cerebral infarction (new or reappeared);
- new or recurrent malignant arrhythmias (ventricular tachycardia/ventricular fibrillation, atrial flutter/atrial fibrillation, hemodynamically unstable second/third degree atrioventricular block);
Measured: Within 3-7 days after surgery
Secondary outcomes (2)
The Postoperative Quality of Recovery-15 scale (QoR-15)
The Postoperative Quality of Recovery-15 scale (QoR-15) on the 1st and 3rd postoperative days.The Postoperative Quality of Recovery-15 scale (QoR-15) on the 1st and 3rd postoperative days. The score ranges from 0 to 150, with higher scores indicating better postoperative recovery.
Measured: Postoperative day 1 and postoperative day 3
Other complications that occurred during postoperative hospitalization
Respiratory complications, lower extremity venous thrombosis/pulmonary embolism, renal failure, surgical site infection
Measured: Until three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Mar 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Adverse Cardiac EventsStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huan Zhang, PhD, Principal investigator, Beijing Tsinghua Changgeng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391632
- Sponsor's protocol ID
- ZB009
- Status last verified
- Mar 2024
- First submitted
- 7 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Prediction Model for Severe Cardiovascular and Cerebrovascular Complications in Elderly Patients After Elective Non-cardiac Surgery: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06391632
- Acronym / sponsor ID
- ZB009
- Conditions
- Major Adverse Cardiac Events, Cerebrovascular Accident, Postoperative Complications, Models
- Keywords
- Elderly patients, Elective non-cardiac surgery, MACCEs, Postoperative Complications, Selective Operation, predictive model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 30 Apr 2024 (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.
Severe cardiovascular and cerebrovascular complications, including cardiac death, non-fatal angina/myocardial infarction, non-fatal heart failure, stroke, severe arrhythmia, etc., are one of the main types of postoperative complications in elderly patients, and are also the main causes of perioperative death in elderly patients. With the aging population and the large proportion of elderly patients undergoing non-cardiac surgery, it is increasingly important to establish a prediction model for postoperative severe cardiovascular and cerebrovascular events in elderly patients undergoing noncardiac surgery.
Detailed description
This project intends to use a multi-center, prospective cohort study method to include about 3000 elderly patients over 65 years old who are planning to undergo non-cardiac surgery, collect relevant data before, during and after surgery, observe the occurrence of serious cardiovascular and cerebrovascular complications in the perioperative period, establish a "MACCE risk prediction model for elderly patients after elective non-cardiac surgery", and verify its effectiveness and reliability. The results of this study will help to improve the predictive ability of postoperative complications of severe cardiovascular and cerebrovascular events in elderly patients undergoing elective non-cardiac surgery, which is conducive to early risk assessment, risk classification, strengthening perioperative patient management, reducing the incidence of postoperative MACCE, and improving the prognosis of elderly patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| positive event group | – | Diagnostic Test: Revised Cardiac Risk IndexThe following complications occur within 3-7 days after surgery： 1. all-cause death; 2. non-fatal myocardial infarction/angina pectoris (new or recurring); 3. non-fatal heart failure (new onset or recurrence); 4. non-fatal cerebral infarction (new or reappeared); 5. new or recurrent malignant arrhythmias (ventricular tachycardia/ventricular fibrillation, atrial flutter/atrial fibrillation, hemodynamically unstable second/third degree atrioventricular block); |
| negative event group | – | Diagnostic Test: Revised Cardiac Risk IndexThe following complications did not occur within 3-7 days after surgery： 1. all-cause death; 2. non-fatal myocardial infarction/angina pectoris (new or recurring); 3. non-fatal heart failure (new onset or recurrence); 4. non-fatal cerebral infarction (new or reappeared); 5. new or recurrent malignant arrhythmias (ventricular tachycardia/ventricular fibrillation, atrial flutter/atrial fibrillation, hemodynamically unstable second/third degree atrioventricular block); |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over 65 years of age undergoing elective non-cardiac surgery
Key inclusion criteria (3 listed)
- The subjects were patients with elective non-cardiac surgery;
- Older than 65 years;
- Patients signed informed consent.
Key exclusion criteria (6 listed)
- The anesthesia should be received in any of the following ways: local anesthesia;
- local anesthesia enhancement, and simple nerve block anesthesia;
- Patients who are scheduled to undergo day surgery;
- Expected operation time <1 hour for patients;
- Patients who are expected to stay in hospital for less than 3 days after surgery;
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 |
|---|---|---|
| Revised Cardiac Risk IndexAlso: Frailty index scale, The Quality of Recovery-15 scaleThe Revised Cardiac Risk Index (RCRI) attempts to estimate the likelihood of cardiac complications during hospitalization in patients undergoing noncardiac surgery.The Frailty Index is a commonly used tool in clinical practice to assess the degree of frailty in patients.The Quality of Recovery-15 scale (QoR-15) is an easy-to-use score for assessing the quality of post-operative recovery. | Diagnostic test | negative event group, positive event group |
Primary outcome
Major Adverse Cardiac and Cerebrovascular event（MACCE）occurred in elderly patients after elective non-cardiac surgery
Time frame: Within 3-7 days after surgery
1. all-cause death; 2. non-fatal myocardial infarction/angina pectoris (new or recurring); 3. non-fatal heart failure (new onset or recurrence); 4. non-fatal cerebral infarction (new or reappeared); 5. new or recurrent malignant arrhythmias (ventricular tachycardia/ventricular fibrillation, atrial flutter/atrial fibrillation, hemodynamically unstable second/third degree atrioventricular block);
2 secondary outcomes
The Postoperative Quality of Recovery-15 scale (QoR-15)
Time frame: Postoperative day 1 and postoperative day 3
Other complications that occurred during postoperative hospitalization
Time frame: Until three months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Huan Zhang, PhD principal investigator
Beijing Tsinghua Changgeng 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 Cerebrovascular Accident, run by Beijing Tsinghua Chang Gung 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 3 inclusion and 6 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 30 Apr 2024. 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?
Contact Huan Zhang, PhD (17800822861, yhls01581@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac and Cerebrovascular event（MACCE）occurred in elderly patients after elective non-cardiac surgery (time frame: Within 3-7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2024.