- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04824001
Exercise Echocardiography on LV Mechanics in Patients With CAD: a Speckle-tracking Echocardiography
26. mars 2021 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Forventet)
90
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Taichung
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Wufeng, Taichung, Taiwan, 413
- Rekruttering
- Asia University Hospital
-
Hovedetterforsker:
- Yu-Chieh Huang, PhD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
N/A
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
acute myocardial infarction diagnosed by a physician and undergoing percutaneous coronary intervention
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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).
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The alterations of LV mechanics responses to a 3-min low dose exercise stress echocardiography following time.
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cardiopulmonary fitness
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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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
Tidsramme: 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.
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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.
|
|
The creatine kinase-MB (CK-MB) levels
Tidsramme: 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
Tidsramme: 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.
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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
Tidsramme: 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.
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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
Tidsramme: 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]
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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
Tidsramme: 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.
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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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: LI-Wei Chou, PhD, China Medical University Hospital/Asia University Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. januar 2021
Primær fullføring (Forventet)
31. juli 2022
Studiet fullført (Forventet)
31. juli 2022
Datoer for studieregistrering
Først innsendt
26. februar 2021
Først innsendt som oppfylte QC-kriteriene
26. mars 2021
Først lagt ut (Faktiske)
1. april 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. april 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. mars 2021
Sist bekreftet
1. mars 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CMUH108-REC2-180
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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