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临床试验/NCT05960214
NCT05960214已完成不适用

Management of Patients With Thalassemia Minor and Breast Cancer at CardioOncology Outpatient Clinics: Age Quod Agis (AQUA)

Istanbul University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Incidence of any rise in troponin

研究概览

简要总结

This retrospective study aimed to evaluate the demographic characteristics, clinical conditions in term of physical examination findings), functional status, and laboratory results of patients with thalassemia minor (TM) and breast cancer (BC) in order to identify any differences between the group with BC only.

Available data as anticancer treatment, comorbidities, weight and height will be combined to report body mass index (BMI) in kg/m2, systolic and diastolic blood pressure, heart rate, ECG, transthoracic echocardiography, blood count, lipid panels, glucose, kidney function tests, (N terminal) NT-proBNP, troponins, handgrip assessments, functional status were extracted from patients files and hospital electronic archives.

详细描述

Following data was extracted from files and hospital electronic records, and will be evaluated (at baseline, 3, 6, 9 and 12 months):

  1. Physical examination findings (as pretibial edema, jugular venous distension, lung rales),
  2. Clinically significant changes in cardiac function as determined by Left Ventricular Ejection Fraction (LVEF) measurements using transthoracic echocardiography,
  3. Any changes in (N terminal) NT-ProBNP and troponin,
  4. Any changes in manual handgrip measurements for both hands using hydraulic hand dynamometer,
  5. Applied medications,

were extracted and will be evaluated.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with diagnosis of breast cancer, and thalassemia minor,
  • >18 years old,
  • Referred by oncologist for cardiac evaluation.
  • Patients with available cardiac evaluations data at baseline and during breast cancer treatment

排除标准

  • Patients without diagnosis of breast cancer, and thalassemia minor,
  • <18 years old,
  • Patients without any cardiac evaluations at baseline, and during cancer treatment.
  • Patients with history of any cardiotoxic treatment prior to enrolment.

结局指标

主要结局

Incidence of any rise in troponin

时间窗: From enrollment to 12 months

Troponin results from baseline and at 3, 6 and 12 months of cancer treatment .

Incidence of any rise in NT-ProBNP

时间窗: From enrollment to 12 months

NT-ProBNP results from baseline and at 3, 6 and 12 months of cancer treatment .

Incidence of any reduction in LV

时间窗: From enrollment to 12 months

Echocardiographic measurements of Left ventricle (LV) ejection fraction from baseline and at 3, 6 and 12 months of cancer treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cafer Zorkun

Associate Professor

Istanbul University

研究点 (1)

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