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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05392426
Other study ID # GLS and Myocardial injury
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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