2D Speckle-tracking Echocardiography in Chemotherapy-induced Cardiomyopathy With Cardiovascular Risk Factors

NCT04547465 | Unknown DMC

• 1 other identifier: 230/HĐĐĐ-ĐHYD
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study is to evaluate the role of 2D speckle-tracking echocardiography in diagnosis chemotherapy related left ventricular dysfunction in breast cancer patients with cardiovascular risks

Conditions

Cardiomyopathy Due to Drug; Breast Cancer; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (5)

• The incidence of chemotherapy induced cardiomyopathy in breast cancer patients with cardiovascular risk

  the incidence

  two year follow-up

• The kinetics of left ventricular global longitudinal strain (LV-GLS) in breast cancer patients treated by anthracycline and/or trastuzumab

  global longitudinal strain (percentage)

  two year follow-up

• The cut-off value of global longitudinal strain (GLS) to predict chemotherapy induced cardiomyopathy in breast cancer patients treated by anthracycline and/or trastuzumab

  global longitudinal strain (percentage)

  two year follow-up

• The kinetics of right ventricular longitudinal strain (RV-GLS and RV-FWLS) in breast cancer patients treated by anthracycline and/or trastuzumab

  longitudinal strain (percentage)

  two year follow-up

• The kinetics of left atrial longitudinal strain (LASr, LAScd, LASct) in breast cancer patients treated by anthracycline and/or trastuzumab

  longitudinal strain (percentage)

  two year follow-up

Interventions

Echocardiography DIAGNOSTIC_TEST

2D Speckle-tracking echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients treated by anthracycline and/or trastuzumab with at least one of the cardiovascular risk factors

You may qualify if:

• Breast cancer patients treated by anthracycline and/or trastuzumab
• Have at least one of these cardiovascular risks: age \> 60, hypertension, atrial fibrillation, diabetes mellitus, dyslipidemia, chronic kidney disease, obesity, family history of cardiovascular diseases.

You may not qualify if:

• Left ventricular ejection fraction \< 50% before chemotherapy
• Chronic heart failure with NYHA functional class \>= II
• Significant valvular stenosis/regurgitation
• Acute heart failure due to acute coronary syndrome during follow-up

Sponsors & Collaborators

• Gia Dinh People Hospital: lead

Study Sites (1)

Nguyen Hoang Hai

Ho Chi Minh City, Vietnam

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Hai H. Nguyen, Ph.D

  Cardiology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nhat M. Giang, M.D

CONTACT

+84919963999; minhnhat210189@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 14, 2020
• Study Start: September 15, 2020
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 8, 2023

Record last verified: 2022-08

Locations

VN (1)