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

• Conditions: Radiation Therapy

• Registration Number: NCT04443400
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2020-01-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-21
• Study First Submitted QC: 2020-06-21
• Last Update Submitted: 2020-06-21
• Study First Posted: 2020-06-23
• Last Update Posted: 2020-06-23
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China