NCT05392426

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

7 months

First QC Date

May 18, 2022

Last Update Submit

June 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Incidence of postoperative arrhythmia events

    from the ending of surgery to 72 hours after surgery

  • Incidence of postoperative myocardial infarct events

    from the ending of surgery to 72 hours after surgery

Interventions

Left Ventricular Global Longitudinal Strain is collected from Speckle tracking imaging (STI) technique of echocardiography. This index is tested before and after the surgery.

Ejection fraction、cardiac output、stroke volume、end diastolic volume、end systolic volume. These indexes are collected before and after the surgery, using traditional echocardiography.

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

The second affiliated hospital of Chongqing medical university

Chongqing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood will be collected for biochemical testing.

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • He Huang, MD

    The Second Affiliated Hospital, Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 26, 2022

Study Start

May 30, 2022

Primary Completion

December 30, 2022

Study Completion

June 1, 2023

Last Updated

June 21, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

The individual participant data for this study is available from the sponsor on reasonable request through email.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Within five years

Locations