Actively Recruiting
Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With Acute Myeloid Leukemia
Led by Samara State Medical University · Updated on 2024-11-05
100
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Acute myeloid leukemia (AML) is a disease where immature blood cells grow uncontrollably due to a mutation. This condition is treated with anthracycline antibiotics, which have been used since the 1970s. However, these drugs can harm the heart, causing problems like heart failure and irregular heartbeats. This trial aims to improve early detection of heart and blood vessel problems related to chemotherapy in AML patients by using detailed tests and measurements. Participants will receive chemotherapy containing anthracyclines and cytarabine following a standard regimen. The study compares two groups of AML patients aged 18 to 65, all without signs of heart failure and with normal heart function initially. One group shows a decrease in heart muscle strain during treatment, while the control group does not. Various diagnostic tests, including laser Doppler flowmetry, stress echocardiography, blood tests for heart and vessel markers, and imaging scans, will be performed before and after each chemotherapy course. Participants will undergo multiple assessments such as history taking, body measurements, blood tests, heart imaging, and vessel scans throughout up to 10 months of chemotherapy treatment. The study will measure changes in heart muscle strain, microcirculation, and biochemical markers after each chemotherapy cycle to find early signs of heart and vascular damage. This information will help develop an algorithm for early detection of heart complications in AML patients receiving chemotherapy.
CONDITIONS
Brief Title
Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with acute myeloid leukemia receiving anthracycline-containing chemotherapy aged 18 to 65 years
- No clinical signs of heart failure
- Left ventricular ejection fraction above 50% before starting chemotherapy
- Provided informed consent to participate in the study
You will not qualify if you...
- History of stroke (acute cerebral circulation disorder)
- History of heart attack (myocardial infarction)
- Diagnosis of type I or II diabetes mellitus
- Chronic kidney disease stages C1 to C5
- Stable angina functional classes III or IV
- Unstable angina pectoris
- Atrial fibrillation or flutter
- Arterial hypertension grades 2 or 3
- Other cancer diseases
- Acute inflammatory diseases
- Thyroid gland diseases
- Previous treatment with monoclonal antibodies
- Positive test for HIV, hepatitis B, or hepatitis C
- Alcohol or drug addiction
- Neuroleukemia or extramedullary leukemia lesions
- Refusal to be examined or continue examination
- Life-threatening situations occurring during the study
- Development of diseases related to exclusion criteria during the study period
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 months
Participants undergo comprehensive diagnostic tests before starting chemotherapy and after each course of chemotherapy, including blood tests, echocardiography, laser Doppler flowmetry, ultrasound, and other assessments to monitor heart and endothelial function.
Visits within 1 week after each chemotherapy course
Trial Site Locations
Total: 1 location
1
Clinics of the Samara Medical University
Samara, Samara Oblast, Russia, 443079
Actively Recruiting
Research Team
I
Igor Davydkin, Doctor of Medical Sciences
A
Angelika Antipova
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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