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

Radiation Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04443400
• Other study ID #: PekingUTN
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2020
• Source: Peking University Third Hospital
• Contact: Dan Zhu, M.D.
• Phone: +8613810103532
• Email: andrea_zhu[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Radiation Therapy

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy	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