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Left Ventricular Global Longitudinal Strain and Postoperative Myocardial Injury

17. juni 2022 opdateret af: The Second Affiliated Hospital of Chongqing Medical University

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.

Studieoversigt

Status

Rekruttering

Betingelser

Postoperative komplikationer

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Qiao Guo, MD
Telefonnummer: (+86)13637870013
E-mail: guoqiao@cqmu.edu.cn

Studiesteder

Kina
- - Chongqing, Kina
    - Rekruttering
    - The Second Affiliated Hospital of Chongqing Medical University
    - Kontakt:
      
      He Huang, doctor
- Chongqing
  - Chongqing, Chongqing, Kina, 400010
    - Rekruttering
    - Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
    - Kontakt:
      
      He Huang, M.D.
      
      Telefonnummer: (+86)13708385559
      
      E-mail: huanghe@cqmu.edu.cn

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år til 90 år (Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Observationsmodeller: Kohorte
Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Postoperative high-sensitive troponin I change Tidsramme: 15 minutes after the ending of the surgery	high-sensitive troponin I will be tested before and after surgery	15 minutes after the ending of the surgery

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Forekomst af postoperative arytmier Tidsramme: fra operationens afslutning til 72 timer efter operationen	postoperative arytmier registreres i henhold til opfølgende besøg efter operationen	fra operationens afslutning til 72 timer efter operationen
Incidence of postoperative myocardial infarct events Tidsramme: from the ending of surgery to 72 hours after surgery	postoperative myocardial infarct events are recorded according to follow-up visits after surgery	from the ending of surgery to 72 hours after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Efterforskere

Ledende efterforsker: He Huang, MD, The Second Affiliated Hospital, Chongqing Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. maj 2022

Primær færdiggørelse (Forventet)

30. december 2022

Studieafslutning (Forventet)

1. juni 2023

Datoer for studieregistrering

Først indsendt

18. maj 2022

Først indsendt, der opfyldte QC-kriterier

23. maj 2022

Først opslået (Faktiske)

26. maj 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juni 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juni 2022

Sidst verificeret

1. juni 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

GLS and Myocardial injury

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

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

IPD-delingstidsramme

Within five years

IPD-deling Understøttende informationstype

Studieprotokol
Statistisk analyseplan (SAP)
Formular til informeret samtykke (ICF)
Klinisk undersøgelsesrapport (CSR)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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