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Exercise Echocardiography on LV Mechanics in Patients With CAD: a Speckle-tracking Echocardiography

26 marzo 2021 aggiornato da: Li-Wei Chou, China Medical University Hospital

Using Exercise Echocardiography to Investigate the Effects of Different Exercise Trainings on Left Ventricular Mechanics in Patients With Coronary Artery Disease: a Speckle-tracking Echocardiography

Recovering blood flow to a coronary stenosis may improve left ventricular (LV) function in patients with coronary artery disease (CAD). However, the reported data about evaluation of LV function post-percutaneous coronary intervention (PCI) in CAD was limited. The aim of this study was to compare the LV function measured by 3 min low dose exercise stress echocardiography (ESE) combined 2D speckle tracking echocardiography (STE) in patients with CAD underwent PCI, and to identify factors affecting the change of LV function. Patients with CAD who underwent acute PCI were enrolled.

Panoramica dello studio

Stato

Sconosciuto

Descrizione dettagliata

The assessment of temporal changes in systolic and diastolic regional left ventricle function by 2D-STE after successful reperfusion therapy of acute myocardial infarction (AMI).The estimated total number of participants is 90 patients with AMI and treated with successful percutaneous coronary intervention were included in this study. The echocardiographic measurements were performed in all patients within in-hotpital after PCI procedure, and then followed up at 7, 14, 30, 60 and 180 days after discharge. Recovery of regional systolic and diastolic myocardial function after acute myocardial infarction evaluated by ESE-STE.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

90

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Taichung
      • Wufeng, Taichung, Taiwan, 413
        • Reclutamento
        • Asia University Hospital
        • Investigatore principale:
          • Yu-Chieh Huang, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

20 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

N/A

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

acute myocardial infarction diagnosed by a physician and undergoing percutaneous coronary intervention

Descrizione

Inclusion Criteria:

  • acute myocardial infarction diagnosed by a physician
  • undergoing percutaneous coronary intervention
  • Exercise testing and stress echocardiography are performed with the approval of the physician.

Exclusion Criteria:

  • Severe cardiac valve disease
  • Left bundle branch block
  • Uncontrolled diabetes or hypertension
  • Orthopedics or other conditions that hinder from exercise
  • Uncontrolled sinus tachycardia (greater than 120 beats per minute)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
STEMI
ST-segment elevation myocardial infarction (STEMI) is defined by symptoms of myocardial ischemia accompanied by a persistent elevation of the ST segment on the electrocardiogram (ECG) and the subsequent release of biomarkers of myocardial necrosis.
Stress echocardiography test. The standardized exercise test was conducted by 50-W semi-recumbent cycling for 3 min. Stress echocardiograph images were acquired at the third minute of cycling to ensure that subjects had reached a steady-state HR.
NSTEMI
If there is elevation of the blood markers suggesting heart damage, but no ST elevation seen on the EKG tracing, this is known as a non ST-elevation myocardial infarction (NSTEMI).
Stress echocardiography test. The standardized exercise test was conducted by 50-W semi-recumbent cycling for 3 min. Stress echocardiograph images were acquired at the third minute of cycling to ensure that subjects had reached a steady-state HR.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The alterations of LV mechanics responses to a 3-min low dose exercise stress echocardiography following time.
Lasso di tempo: detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.
The STE was performed at rest, during exercise and recovery to compare the changes of LV machines following discharge. The standardized exercise test was conducted by 50-W semirecumbent cycling (Cardiac Stress Table w/Angio) for 3 min. Stress echocardiograph images were acquired at the third minute of cycling to ensure that subjects had reached a steady-state HR.
detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cardiopulmonary fitness
Lasso di tempo: detected at the day 30, 60, and 180 after discharge.
The graded exercise test (GXT) was performed with a cycle ergometer at the day 30 and 180 after discharge. The GXT comprised of unloaded pedaling for 2 min followed by a continuous increase in work rate (20-30 W) every 3 min until exhaustion (i.e., V˙ O2max). Minute ventilation (V˙ E), V˙ O2, and CO2 production (V˙ CO2) were measured breath-by-breath using a computer-based system (MasterScreen CPX; Cardinal Health Germany).
detected at the day 30, 60, and 180 after discharge.
The brain-type natriuretic peptide (BNP) levels
Lasso di tempo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
BNP levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
The high-sensitivity CRP (hsCRP) levels
Lasso di tempo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
hsCRP levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
The creatine kinase (CK) levels
Lasso di tempo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
The CK levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
The creatine kinase-MB (CK-MB) levels
Lasso di tempo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
The CK-MB levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
The troponin I levels
Lasso di tempo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
The troponin I levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
The left ventricle wall and cavity dimensions
Lasso di tempo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
M-mode images were used to determine the LV wall and cavity dimensions at end-systole and end-diastole from a parasternal long axis view.
detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
The left ventricle mass
Lasso di tempo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
Measurements of LVmass and the short fraction index were automatically derived using standard equations as followed: LVmass(gm) = 0.77 X 10^-3X [(IVS + LVIDd +PW)^3 - (LVIDd)^3 + 2.4]
detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
The left ventricle ejection fraction
Lasso di tempo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
LV ejection fraction (LVEF) was determined using the modified Simpson's method from the apical four-chamber views.
detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
The left ventricle diastolic functions
Lasso di tempo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
Analysis of Doppler pulsed wave was performed to determine diastolic transmitral blood flow velocities for peak early (E) and late (A) fillings and was also detected the diastolic mitral annular tissue velocities for peak early (E') and late (A') fillings.
detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: LI-Wei Chou, PhD, China Medical University Hospital/Asia University Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 gennaio 2021

Completamento primario (Anticipato)

31 luglio 2022

Completamento dello studio (Anticipato)

31 luglio 2022

Date di iscrizione allo studio

Primo inviato

26 febbraio 2021

Primo inviato che soddisfa i criteri di controllo qualità

26 marzo 2021

Primo Inserito (Effettivo)

1 aprile 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 aprile 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 marzo 2021

Ultimo verificato

1 marzo 2021

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CMUH108-REC2-180

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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