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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04824001
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
Condizioni
Intervento / Trattamento
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
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Taichung
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Wufeng, Taichung, Taiwan, 413
- Reclutamento
- Asia University Hospital
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Investigatore principale:
- Yu-Chieh Huang, PhD
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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 |
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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.
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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.
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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).
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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.
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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.
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detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Cardiopulmonary fitness
Lasso di tempo: detected at the day 30, 60, and 180 after discharge.
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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).
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detected at the day 30, 60, and 180 after discharge.
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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.
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BNP levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
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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.
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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.
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hsCRP levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
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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.
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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.
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The CK levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
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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.
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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.
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The CK-MB levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
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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.
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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.
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The troponin I levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
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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.
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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.
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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.
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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.
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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.
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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]
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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.
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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.
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LV ejection fraction (LVEF) was determined using the modified Simpson's method from the apical four-chamber views.
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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.
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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.
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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.
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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.
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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.
Pubblicazioni generali
- Huang YC, Tsai HH, Fu TC, Hsu CC, Wang JS. High-Intensity Interval Training Improves Left Ventricular Contractile Function. Med Sci Sports Exerc. 2019 Jul;51(7):1420-1428. doi: 10.1249/MSS.0000000000001931.
- Anand IS, Kuskowski MA, Rector TS, Florea VG, Glazer RD, Hester A, Chiang YT, Aknay N, Maggioni AP, Opasich C, Latini R, Cohn JN. Anemia and change in hemoglobin over time related to mortality and morbidity in patients with chronic heart failure: results from Val-HeFT. Circulation. 2005 Aug 23;112(8):1121-7. doi: 10.1161/CIRCULATIONAHA.104.512988. Epub 2005 Aug 15.
- Sikora-Frac M, Zaborska B, Maciejewski P, Budaj A, Bednarz B. Improvement of left ventricular function after percutaneous coronary intervention in patients with stable coronary artery disease and preserved ejection fraction: Impact of diabetes mellitus. Cardiol J. 2021;28(6):923-931. doi: 10.5603/CJ.a2019.0066. Epub 2019 Jul 1.
- Li H, Liu C, Zhang G, Wang C, Sun P, Du G, Tian J. The early alteration of left ventricular strain and dys-synchrony index in breast cancer patients undergoing anthracycline therapy using layer-specific strain analysis. Echocardiography. 2019 Sep;36(9):1675-1681. doi: 10.1111/echo.14460. Epub 2019 Aug 27.
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
Parole chiave
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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