Left Ventricular Global Longitudinal Strain and Postoperative Myocardial Injury

Postoperative Complications Clinical Trial

Official title:

High-sensitive Troponin I Increase After Surgery is Associated With Left Ventricular Global Longitudinal Strain Among Patients With Elderly Coronary Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05392426
• Other study ID #: GLS and Myocardial injury
• Status: Recruiting
• Start date: May 30, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2022
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Qiao Guo, MD
• Phone: (+86)13637870013
• Email: guoqiao[@]cqmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The study was designed according to a prospective follow-up cohort.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: June 1, 2023
• Est. primary completion date: December 30, 2022
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age 65-90;

2. 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;

3. ASA II~III; NYHA II~III; require general anesthesia;

4. no history of anesthetic allergy;

5. agreed to participate in the study and signed the informed consent form.

Exclusion Criteria:

1. Congenital heart disease, severe ventricular arrhythmia, atrial fibrillation, severe valvular regurgitation;

2. Severe history of chronic obstructive pulmonary illness (COPD severity III or IV), individuals with severe or uncontrolled bronchial asthma, pulmonary infection, bronchiectasis;

3. Patients with persistent drinking and known or suspected abusers of other narcotic analgesics;

4. Obese (BMI 30 kg/m2)

5. Cardiac surgical procedures are planned.

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Device:
• Left Ventricular Global Longitudinal Strain
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 ESV
Ejection fraction?cardiac output?stroke volume?end diastolic volume?end systolic volume. These indexes are collected before and after the surgery, using traditional echocardiography.

Locations

Country	Name	City	State
China	Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing
China	The second affiliated hospital of Chongqing medical university	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative high-sensitive troponin I change	high-sensitive troponin I will be tested before and after surgery	15 minutes after the ending of the surgery
Secondary	Incidence of postoperative arrhythmia events	postoperative arrhythmia events are recorded according to follow-up visits after surgery	from the ending of surgery to 72 hours after surgery
Secondary	Incidence of postoperative myocardial infarct events	postoperative myocardial infarct events are recorded according to follow-up visits after surgery	from the ending of surgery to 72 hours after surgery