Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy

June 21, 2020 updated by: Peking University Third Hospital
The purpose of this study is to detecte and predict early subclinical cardiac damage induced by thoracic radiation therapy based on two-dimensional speckle tracking echocardiography combined with multiple circulating biomarkers.

Study Overview

Status

Unknown

Conditions

Detailed Description

This is a monocentric prospective cohort study in which 100 patients treated for malignant tumors and with cardiac radiation exposure will be included.All patient will be followed for 12 months after radiotherapy. Echocardiography, 2D STE parameters and circulating biomarkers will be collected.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dan Zhu, M.D.
  • Phone Number: +8613810103532 +8613810103532
  • Email: andrea_zhu@163.com

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with thoracic radiotherapy

Description

Inclusion Criteria:

  • with malignant tumors
  • will receive radiotherapy
  • with cardiac exposure during the radiotherapy process
  • could receive regular follow-up for 12 months
  • written informed consent

Exclusion Criteria:

  • satisfactory echocardiographic images could not be obtained
  • moderate or severe valvular disease
  • cardiomyopathy
  • congenital heart disease
  • refractory hypertension
  • coronary artery disease*
  • heart failure
  • arrhythmia requiring intervention
  • pericarditis
  • acute myocarditis
  • participating in other clinical studies of drug intervention
  • severe liver and kidney dysfunction
  • autoimmune disease
  • pulmonary hypertension

coronary artery disease: at least 50% stenosis besed on previous coronary angiography or CTA, or with a history of percutaneous coronary stent implantation.

*: with LVEF<50%, unstable angina，or acute myocardial infarction within 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy
Time Frame: 2020-2021
To detecte early subclinical cardiac damage induced by thoracic radiation therapy, based on two-dimensional speckle tracking echocardiography combined with multiple circulating biomarkers
2020-2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Study Director: Dan Zhu, Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

June 21, 2020

First Submitted That Met QC Criteria

June 21, 2020

First Posted (ACTUAL)

June 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 21, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • PekingUTN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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