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Trial Title:
Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy
NCT ID:
NCT05728788
Condition:
Cancer Therapy-related Cardiovascular Toxicity
Conditions: Official terms:
Antineoplastic Agents
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Antitumor drugs
Description:
Anthracyclines, immune checkpoint inhibitors, monoclonal antibodies, and tyrosine kinase
inhibitors
Arm group label:
Patients treated with antineoplastic agents
Summary:
The purpose of this study was to explore the relationship between early myocardial injury
caused by tumor drug therapy and intestinal microbial structure changes by
echocardiographic two-dimensional speckle tracking technique and intestinal microflora
structure detection.
Detailed description:
This is a monocentric prospective cohort study in which 50 patients treated for malignant
tumors will be included. All participants will be followed for 6 months after the
initiation of oncology drug therapy. Echocardiography and 2D speckle tracking will be
performed and stool and blood samples will be tested before treatment initiation and at 3
and 6 months after initiation.
Criteria for eligibility:
Study pop:
Patients treated with antineoplastic agents
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- With malignant tumors
- Will receive antitumor drugs
- Could receive regular follow-up for 6 months
- Written informed consent
Exclusion Criteria:
- Satisfactory echocardiographic images could not be obtained
- Cardiomyopathy
- Coronary artery disease
- Heart failure
- Arrhythmia requiring intervention
- Moderate or severe valvular disease
- Acute myocarditis
- Refractory hypertension
- Participating in other studies of drug intervention
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhenyu Tian
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhenyu Tian
Phone:
+8613051871220
Email:
tzy003@126.com
Investigator:
Last name:
Ming Cui
Email:
Principal Investigator
Start date:
July 1, 2022
Completion date:
December 1, 2023
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05728788
