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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04824001
• Other study ID #: CMUH108-REC2-180
• Status: Recruiting
• Start date: January 13, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: March 2021
• Source: China Medical University Hospital
• Contact: LI-Wei Chou, PhD
• Phone: +886-4-22052121
• Email: chouliwe[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• NSTEMI
• STEMI

Intervention

Other:
• exercise stress echocardiography
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.

Locations

Country	Name	City	State
Taiwan	Asia University Hospital	Wufeng	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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. Epub 2005 Aug 15. — View Citation

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. — View Citation

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. — View Citation

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. 2019 Jul 1. doi: 10.5603/CJ.a2019.0066. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The alterations of LV mechanics responses to a 3-min low dose exercise stress echocardiography following time.	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.
Secondary	Cardiopulmonary fitness	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.
Secondary	The brain-type natriuretic peptide (BNP) levels	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.
Secondary	The high-sensitivity CRP (hsCRP) levels	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.
Secondary	The creatine kinase (CK) levels	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.
Secondary	The creatine kinase-MB (CK-MB) levels	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.
Secondary	The troponin I levels	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.
Secondary	The left ventricle wall and cavity dimensions	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.
Secondary	The left ventricle mass	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.
Secondary	The left ventricle ejection fraction	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.
Secondary	The left ventricle diastolic functions	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.