NCT04443400

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

June 21, 2020

Last Update Submit

June 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with thoracic radiotherapy

You may qualify if:

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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (2)

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

blood samples will be collected

Study Officials

  • Dan Zhu

    Peking University Third Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2020

First Posted

June 23, 2020

Study Start

January 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 23, 2020

Record last verified: 2020-06

Locations