NCT04824001

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 26, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

February 26, 2021

Last Update Submit

March 26, 2021

Conditions

Keywords

stress echocardiographyspeckle tracking

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Cardiopulmonary fitness

    detected at the day 30, 60, and 180 after discharge.

  • The brain-type natriuretic peptide (BNP) levels

    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

    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 (CK) levels

    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

    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.

  • +5 more secondary outcomes

Study Arms (2)

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

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

Interventions

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.

NSTEMISTEMI

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

acute myocardial infarction diagnosed by a physician and undergoing percutaneous coronary intervention

You may qualify if:

  • acute myocardial infarction diagnosed by a physician
  • undergoing percutaneous coronary intervention
  • Exercise testing and stress echocardiography are performed with the approval of the physician.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asia University Hospital

Wufeng District, Taichung, 413, Taiwan

RECRUITING

Related 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. doi: 10.1161/CIRCULATIONAHA.104.512988. Epub 2005 Aug 15.

    PMID: 16103233BACKGROUND
  • 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.

    PMID: 31257568BACKGROUND
  • 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.

    PMID: 31454106BACKGROUND
  • 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.

    PMID: 30829901BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesST Elevation Myocardial InfarctionNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • LI-Wei Chou, PhD

    China Medical University Hospital/Asia University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Minister of Rehabilitation

Study Record Dates

First Submitted

February 26, 2021

First Posted

April 1, 2021

Study Start

January 13, 2021

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations