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

NCT06206395 | Unknown

• 1 other identifier: Cardiotoxicity and cancer
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

2D Speckle Tracking Echocardiography; Breast Cancer; Cardiac Magnetic Resonance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cancer patients receiving chemotherapeutic drugs

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

Device: Two dimensions speckle tracking and three dimension echocardiography and cardiac magnetic resonance imaging

Interventions

Two dimensions speckle tracking and three dimension echocardiography and cardiac magnetic resonance imaging DEVICE

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.

Cancer patients receiving chemotherapeutic drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cancer patients receiving chemotherapeutic drugs with or without adjuvant radiotherapy at oncology department of Assiut University Hospital will be enrolled and imaging modalities will be performed at Assiut University Heart Hospital.

You may qualify if:

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

You may not qualify if:

• 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%).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University-Cardiovascular department

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John S Johny, MSC

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John S Johny, MSC

CONTACT

01201045287; johnsafwatjohny91@yahoo.com

Shaima S Hassan, MD

CONTACT

01001346551; shaimaakhidr@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assiut University

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: January 16, 2024
• Study Start: February 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

EG (1)