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

NCT ID: NCT04443400

Last Updated: 2020-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Radiation Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan Zhu

Role: STUDY_DIRECTOR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dan Zhu, M.D.

Role: CONTACT

+8613810103532 ext. +8613810103532

Tingcui Li

Role: CONTACT

+8618801236290 ext. +8618801236290

Facility Contacts

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Dan Zhu

Role: primary

+8613810103532 ext. +8613810103532

Tingcui Li

Role: backup

+8618801236290 ext. +8618801236290

References

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Li T, Zhuang H, Wang Y, Li J, Zhu D, Cui M. Two-dimensional speckle tracking echocardiography in evaluating radiation-induced heart damage. Asia Pac J Oncol Nurs. 2021 Dec 25;9(2):119-124. doi: 10.1016/j.apjon.2021.12.008. eCollection 2022 Feb.

Reference Type DERIVED
PMID: 35529415 (View on PubMed)

Zhu D, Li T, Zhuang H, Cui M. Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy: Study Protocol for a Prospective Cohort Study. Front Cardiovasc Med. 2022 Jan 26;8:735265. doi: 10.3389/fcvm.2021.735265. eCollection 2021.

Reference Type DERIVED
PMID: 35155592 (View on PubMed)

Other Identifiers

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PekingUTN

Identifier Type: -

Identifier Source: org_study_id

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