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

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ClinicalTrials.gov Identifier: NCT04824001
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Li-Wei Chou, China Medical University Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Cardiovascular Diseases STEMI NSTEMI Other: exercise stress echocardiography

Detailed 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 13, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 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.
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).
 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.


Outcome Measures
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Primary Outcome Measures :
  1. The alterations of LV mechanics responses to a 3-min low dose exercise stress echocardiography following time. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Cardiopulmonary fitness [ Time Frame: 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).

  2. The brain-type natriuretic peptide (BNP) levels [ Time Frame: 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.

  3. The high-sensitivity CRP (hsCRP) levels [ Time Frame: 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.

  4. The creatine kinase (CK) levels [ Time Frame: 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.

  5. The creatine kinase-MB (CK-MB) levels [ Time Frame: 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.

  6. The troponin I levels [ Time Frame: 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.

  7. The left ventricle wall and cavity dimensions [ Time Frame: 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.

  8. The left ventricle mass [ Time Frame: 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]

  9. The left ventricle ejection fraction [ Time Frame: 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.

  10. The left ventricle diastolic functions [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
acute myocardial infarction diagnosed by a physician and undergoing percutaneous coronary intervention
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04824001


Contacts
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Contact: LI-Wei Chou, PhD +886-4-22052121 ext 2381 chouliwe@mail.cmuh.org.tw

Locations
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Taiwan
Asia University Hospital Recruiting
Wufeng, Taichung, Taiwan, 413
Contact: Chou Li-Wei, PhD    +886-4-22052121 ext 2381    chouliwe@mail.cmuh.org.tw   
Principal Investigator: Yu-Chieh Huang, PhD         
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Principal Investigator: LI-Wei Chou, PhD China Medical University Hospital/Asia University Hospital
More Information
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Publications:

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Responsible Party: Li-Wei Chou, Minister of Rehabilitation, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04824001    
Other Study ID Numbers: CMUH108-REC2-180
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li-Wei Chou, China Medical University Hospital:
stress echocardiography
speckle tracking
Additional relevant MeSH terms:
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Cardiovascular Diseases