Role of Multi-modality Imaging in the Assessment of Chemotherapy Related Cardiac Dysfunction Among Cancer Patients

Breast Cancer Clinical Trial

Official title:

Assiut University-Egypt

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06206395
• Other study ID #: Cardiotoxicity and cancer
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: John S Johny, MSC
• Phone: 01201045287
• Email: johnsafwatjohny91[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The field of oncology has advanced remarkably. Some of the old and new emerging cancer therapies are associated with development of cardiovascular toxicities , which may have the potential to offset the gains in survival obtained with this cancer treatment advances. Much of the focus on cardiovascular toxicities has been in the early detection of myocardial damage and prediction of cancer therapeutics-related cardiac dysfunction (CTRCD). The main strategy for these patients is timely diagnosis and treatment of high-risk individual Cardiac dysfunction associated with cancer treatment is the main cause of mortality in cancer survivors. The mortality rate is recorded to be up to 60% in the first two years after therapy. The most commonly associated drugs with cardiotoxicity are anthracycline (AC) and monoclonal antibodies (such as trastuzumab). Other new agents, such as vascular endothelial growth factor (VEGF) inhibitors, immunotherapies, and proteasome inhibitors, can also cause cardiac dysfunction .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 190
• Est. completion date: May 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cancer patients = 18 years of age, and scheduled to receive chemotherapy will be included.

Exclusion Criteria:

• Contraindications to CMR (e.g.: patients with pacemakers, defibrillators or other implanted electronic devices).
• Life expectancy = 12 months.
• Participating in another oncology clinical trial;
• Prior exposure to chemotherapy;
• History of active or prior cardiac disease (e.g., myocardial infarction, heart failure or base line left ventricular ejection fraction less than 55%).

Related Conditions & MeSH terms

• Breast Cancer
• Cardiac Magnetic Resonance

Intervention

Device:
• Two dimensions speckle tracking and three dimension echocardiography and cardiac magnetic resonance imaging
2D speckle tracking echo will be performed before chemotherapy and after mid-cycle and after completion of treatment. 3D echo and CMR will be performed before and after chemotherapy treatment.

Locations

Country	Name	City	State
Egypt	Assiut University-Cardiovascular department	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine and compare the role of 2D speckle tracking vs. 3D echocardiography in assessment of early LV systolic dysfunction in patients receiving different chemotherapy combinations	All patient will be undergo both 2D and 3D echocardiography before and after treatment to detect early LV systolic dysfunction.	up to 6 months after starting chemotherapy