Postoperative ComplicationsNCT05392426
Left Ventricular Global Longitudinal Strain and Postoperative Myocardial Injury
An observational study of Postoperative Complications, run by The Second Affiliated Hospital of Chongqing Medical University at 2 sites in China.
Trial summary
To use left ventricular global longitudinal strain as a means of monitoring myocardial exercise function during anaesthesia in patients with coronary artery disease, to explore the association with the occurrence of postoperative myocardial injury, and to perform a predictive study of postoperative myocardial injury. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Left Ventricular Global Longitudinal Strain and EF CO SV EDV ESV
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- 2 sitesChina
- Study dates
- 30 May 2022to 1 Jun 2023
- 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 to 90 years
- All sexes
- Older adult
Study population: According to the European Heart Association's diagnostic criteria for chronic coronary syndrome in 2019, refers to the many stages of coronary heart disease other than the clinical manifestations dominated by acute coronary thrombosis.
Who may be able to join
- Age 65-90;
- According to the European Heart Association's diagnostic criteria for chronic coronary syndrome in 2019.Patients with suspected coronary heart disease and stable angina pectoris, with or without dyspnea; New heart failure or left ventricular dysfunction, suspected coronary heart disease; Patients with acute coronary syndrome who are asymptomatic or stable within one year of onset, or who will undergo revascularization in the near future;Patients with an initial diagnosis or revascularization for more than one year, with or without symptoms; Angina pectoris, suspected vasospasm, or microvascular disease patients; During screening, asymptomatic people with coronary heart disease were discovered;
- ASA II~III; NYHA II~III; require general anesthesia;
- no history of anesthetic allergy;
- agreed to participate in the study and signed the informed consent form.
Who cannot join
- Congenital heart disease, severe ventricular arrhythmia, atrial fibrillation, severe valvular regurgitation;
- Severe history of chronic obstructive pulmonary illness (COPD severity III or IV), individuals with severe or uncontrolled bronchial asthma, pulmonary infection, bronchiectasis;
- Patients with persistent drinking and known or suspected abusers of other narcotic analgesics;
- Obese (BMI 30 kg/m2)
- Cardiac surgical procedures are planned.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
He Huang, M.D., (+86)13708385559, huanghe@cqmu.edu.cn
- Recruiting
The second affiliated hospital of Chongqing medical university
Chongqing
He Huang, doctor
About this study
Official title: High-sensitive Troponin I Increase After Surgery is Associated With Left Ventricular Global Longitudinal Strain Among Patients With Elderly Coronary Heart Disease
To use left ventricular global longitudinal strain as a means of monitoring myocardial exercise function during anaesthesia in patients with coronary artery disease, to explore the association with the occurrence of postoperative myocardial injury, and to perform a predictive study of postoperative myocardial injury. The study was designed according to a prospective follow-up cohort.
Read the detailed description
The incidence and risk of postoperative myocardial injury in patients with coronary artery disease is high, and there is no definitive monitoring tool to predict postoperative myocardial injury. Speckle tracking imaging (STI), which quantifies strain and ventricular torsion in all segments of the heart, is more sensitive to subtle changes in myocardial contractility than conventional ultrasound. This project proposes to use 4D-STI as a means of monitoring myocardial exercise function during anaesthesia in patients with coronary artery disease, to explore the association with the occurrence of postoperative myocardial injury, and to perform a predictive study of postoperative myocardial injury. The study was designed according to a prospective follow-up cohort. The protocol was developed with reference to the STROBE guidelines for cohort studies. In this study, 2.5 ml of venous blood specimens were collected before surgery and at the end of surgery and sent to the laboratory. Intraoperative data collection was performed in the operating theatre and follow-up was obtained on the ward and during telephone follow-up.
- Conditions
- Postoperative Complications
- Being tested
- Left Ventricular Global Longitudinal Strain, EF CO SV EDV ESV
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Ventricular Global Longitudinal StrainDevice
Left Ventricular Global Longitudinal Strain is collected from Speckle tracking imaging (STI) technique of echocardiography. This index is tested before and after the surgery.
EF CO SV EDV ESVDevice
Ejection fraction、cardiac output、stroke volume、end diastolic volume、end systolic volume. These indexes are collected before and after the surgery, using traditional echocardiography.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative high-sensitive troponin I change
high-sensitive troponin I will be tested before and after surgery
Measured: 15 minutes after the ending of the surgery
Secondary outcomes (2)
Incidence of postoperative arrhythmia events
postoperative arrhythmia events are recorded according to follow-up visits after surgery
Measured: from the ending of surgery to 72 hours after surgery
Incidence of postoperative myocardial infarct events
postoperative myocardial infarct events are recorded according to follow-up visits after surgery
Measured: from the ending of surgery to 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start30 May 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- 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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- He Huang, MD, Principal investigator, The Second Affiliated Hospital, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392426
- Sponsor's protocol ID
- GLS and Myocardial injury
- Status last verified
- Jun 2022
- First submitted
- 18 May 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data for this study is available from the sponsor on reasonable request through email.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-sensitive Troponin I Increase After Surgery is Associated With Left Ventricular Global Longitudinal Strain Among Patients With Elderly Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT05392426
- Acronym / sponsor ID
- GLS and Myocardial injury
- Conditions
- Postoperative Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 26 May 2022 (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.
To use left ventricular global longitudinal strain as a means of monitoring myocardial exercise function during anaesthesia in patients with coronary artery disease, to explore the association with the occurrence of postoperative myocardial injury, and to perform a predictive study of postoperative myocardial injury. The study was designed according to a prospective follow-up cohort.
Detailed description
The incidence and risk of postoperative myocardial injury in patients with coronary artery disease is high, and there is no definitive monitoring tool to predict postoperative myocardial injury. Speckle tracking imaging (STI), which quantifies strain and ventricular torsion in all segments of the heart, is more sensitive to subtle changes in myocardial contractility than conventional ultrasound. This project proposes to use 4D-STI as a means of monitoring myocardial exercise function during anaesthesia in patients with coronary artery disease, to explore the association with the occurrence of postoperative myocardial injury, and to perform a predictive study of postoperative myocardial injury. The study was designed according to a prospective follow-up cohort. The protocol was developed with reference to the STROBE guidelines for cohort studies. In this study, 2.5 ml of venous blood specimens were collected before surgery and at the end of surgery and sent to the laboratory. Intraoperative data collection was performed in the operating theatre and follow-up was obtained on the ward and during telephone follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Age groups
- Older adult
- Study population
- According to the European Heart Association's diagnostic criteria for chronic coronary syndrome in 2019, refers to the many stages of coronary heart disease other than the clinical manifestations dominated by acute coronary thrombosis.
Key inclusion criteria (5 listed)
- Age 65-90;
- According to the European Heart Association's diagnostic criteria for chronic coronary syndrome in 2019.Patients with suspected coronary heart disease and stable angina pectoris, with or without dyspnea; New heart failure or left ventricular dysfunction, suspected coronary heart disease; Patients with acute coronary syndrome who are asymptomatic or stable within one year of onset, or who will undergo revascularization in the near future;Patients with an initial diagnosis or revascularization for more than one year, with or without symptoms; Angina pectoris, suspected vasospasm, or microvascular disease patients; During screening, asymptomatic people with coronary heart disease were discovered;
- ASA II~III; NYHA II~III; require general anesthesia;
- no history of anesthetic allergy;
- agreed to participate in the study and signed the informed consent form.
Key exclusion criteria (5 listed)
- Congenital heart disease, severe ventricular arrhythmia, atrial fibrillation, severe valvular regurgitation;
- Severe history of chronic obstructive pulmonary illness (COPD severity III or IV), individuals with severe or uncontrolled bronchial asthma, pulmonary infection, bronchiectasis;
- Patients with persistent drinking and known or suspected abusers of other narcotic analgesics;
- Obese (BMI 30 kg/m2)
- Cardiac surgical procedures are planned.
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 |
|---|---|---|
| Left Ventricular Global Longitudinal StrainLeft Ventricular Global Longitudinal Strain is collected from Speckle tracking imaging (STI) technique of echocardiography. This index is tested before and after the surgery. | Device | – |
| EF CO SV EDV ESVEjection fraction、cardiac output、stroke volume、end diastolic volume、end systolic volume. These indexes are collected before and after the surgery, using traditional echocardiography. | Device | – |
Primary outcome
Postoperative high-sensitive troponin I change
Time frame: 15 minutes after the ending of the surgery
high-sensitive troponin I will be tested before and after surgery
2 secondary outcomes
Incidence of postoperative arrhythmia events
Time frame: from the ending of surgery to 72 hours after surgery
Incidence of postoperative myocardial infarct events
Time frame: from the ending of surgery to 72 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: Yes. The individual participant data for this study is available from the sponsor on reasonable request through email.
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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.
He Huang, MD principal investigator
The Second Affiliated Hospital, Chongqing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by The Second Affiliated Hospital of Chongqing Medical University at 2 sites 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 5 inclusion and 5 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 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Qiao Guo, MD ((+86)13637870013, guoqiao@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative high-sensitive troponin I change (time frame: 15 minutes after the ending of the 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 21 Jun 2022.