Left Ventricular Global Longitudinal Strain and Postoperative Myocardial Injury

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications
• Intervention / Treatment: Device: Left Ventricular Global Longitudinal Strain; Device: EF CO SV EDV ESV

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 Type: Observational
• Enrollment (Anticipated): 58

Contacts and Locations

• Study Contact: Name: Qiao Guo, MD; Phone Number: (+86)13637870013; Email: guoqiao@cqmu.edu.cn

Study Locations

• China
  • Chongqing, China
    • Recruiting
    • The Second Affiliated Hospital of Chongqing Medical University
    • Contact: He Huang, doctor
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Recruiting
      • Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
      • Contact: He Huang, M.D.; Phone Number: (+86)13708385559; Email: huanghe@cqmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Principal Investigator: He Huang, MD, The Second Affiliated Hospital, Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: GLS and Myocardial injury

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The individual participant data for this study is available from the sponsor on reasonable request through email.
• IPD Sharing Time Frame: Within five years
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No