- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04824001
Exercise Echocardiography on LV Mechanics in Patients With CAD: a Speckle-tracking Echocardiography
26. März 2021 aktualisiert von: 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.
Studienübersicht
Status
Unbekannt
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Voraussichtlich)
90
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Taichung
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Wufeng, Taichung, Taiwan, 413
- Rekrutierung
- Asia University Hospital
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Hauptermittler:
- Yu-Chieh Huang, PhD
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
20 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
N/A
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
acute myocardial infarction diagnosed by a physician and undergoing percutaneous coronary intervention
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The alterations of LV mechanics responses to a 3-min low dose exercise stress echocardiography following time.
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Cardiopulmonary fitness
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: LI-Wei Chou, PhD, China Medical University Hospital/Asia University Hospital
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
13. Januar 2021
Primärer Abschluss (Voraussichtlich)
31. Juli 2022
Studienabschluss (Voraussichtlich)
31. Juli 2022
Studienanmeldedaten
Zuerst eingereicht
26. Februar 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
26. März 2021
Zuerst gepostet (Tatsächlich)
1. April 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
1. April 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. März 2021
Zuletzt verifiziert
1. März 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CMUH108-REC2-180
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