Early Detection of Cardiomyopathy by Speckle Echo, High Sensitive Troponin and Cardiac Ryanodine Receptors

Chemotherapy Effect Clinical Trial

Official title:

Added Benefit of Speckle Tracking Echo to Molecular Expression of High Sensitive Troponin I and Cardiac Ryanodine Receptor in Early Detection of Cardiomyopathy in Patients Receiving Anthracycline Chemotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03381014
• Other study ID #: speckle echo in cardiomyopathy
• Status: Not yet recruiting
• Phase: N/A
• First received: December 12, 2017
• Last updated: December 17, 2017
• Start date: January 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: December 2017
• Source: Assiut University
• Contact: Mostafa M Morsy, MD
• Phone: +201096955959
• Email: Mostafa_corono[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Early detection of cardiomyopathy in patients receiving Anthracycline chemotherapy and determine if speckle tracking echo and Troponin gene will add benefit for early detection of cardiomyopathy.

Improve economic impact of oncologic patients from whom high sensitive troponin negative and normal speckle tracking patients can be safely excluded from long-term cardiac monitoring programs.

To correlate between the molecular gene expression of troponin genes and ryanodine receptor in cardiomyopathy

Description:

Anthracycline chemotherapy has saved the lives of many cancer victims during the 50 years after their discovery.These patients are prone to higher risk of cardiovascular death than the risk of tumor recurrence, particularly in childhood cancer survivors in whom the cardiac mortality rate is seven fold higher.

Cardiac toxicity remains an important side effect of anticancer therapies, leading to increased mortality due to mainly heart failure, but also arrhythmias, hypertension, thromboembolism.

The time from early development of cardiac dysfunction to the modification or end of chemotherapy and beginning of heart failure therapy, is an important determinant of the extent of recovery.

The Cardiotoxicity of anthracyclines may be acute, early or late. A recent study involving 2625 patients (mean follow-up 5 years); showed a 9% overall incidence of Cardiotoxicity after anthracycline treatment, 98% of cases occurred within the first year and were asymptomatic.

Cardiotoxicity has been defined using various classifications. Recent guidelines suggest that Cancer therapeutics-related cardiac dysfunction (CTRCD) is defined as a decrease in the LVEF (by echocardiography) of >10 percentage points to a value below the lower limit of normal.

Echocardiography should be repeated before every next administration of anthracycline, after 3, 6, and 12 months from the end of therapy with anthracycline but...Not all patients treated with chemotherapy require such frequently repeated LVEF monitoring as suggested by the guidelines because of the negative impact on patient management and cost-effectiveness ratio for the national health system.

Speckle-tracking echocardiography is a noninvasive ultrasound imaging technique that allows for early an objective and quantitative evaluation of global and regional myocardial function.

New elevation of serum troponin detected with high sensitivity Troponin assays in patients receiving anthracyclines also predicts subsequent LV dysfunction.

Ryanodine receptors (RyRs) are a class of intracellular calcium channels in various forms of excitable tissues like muscles and neurons.

In heart failure the RyR2 channels become abnormally active or "leaky" and are unable to remain closed during diastole. This leads to an increase in spontaneous Ca+2 spark frequency and dysregulated Ca+2 handling within the cardiomyocyte, resulting in decreased systolic contraction and irregular contractile activity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• all Newly diagnosed cancer patients with who will receive Anthracycline based regimen chemotherapy

Exclusion Criteria:

• Insufficient ultrasound image quality, defined as more than three LV segments being suboptimally visualized by conventional echocardiography.

• Valvular heart disease

• Hypertensive heart disease

• Cardiomyopathy

• Chronic renal failure

• Chronic obstructive air way disease (COPD)

Related Conditions & MeSH terms

• Cardiomyopathies
• Chemotherapy Effect

Intervention

Drug:
• Chemotherapy, Cancer, Anthracyclines
follow up cardio-toxicity .... by speckle tracking echo and cardiac troponin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Curigliano G, Cardinale D, Dent S, Criscitiello C, Aseyev O, Lenihan D, Cipolla CM. Cardiotoxicity of anticancer treatments: Epidemiology, detection, and management. CA Cancer J Clin. 2016 Jul;66(4):309-25. doi: 10.3322/caac.21341. Epub 2016 Feb 26. Revie — View Citation

Henning RJ, Harbison RD. Cardio-oncology: cardiovascular complications of cancer therapy. Future Cardiol. 2017 Jul;13(4):379-396. doi: 10.2217/fca-2016-0081. Epub 2017 Jun 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early detection of cardiomyopathy	using speckle tracking echo to early diagnosis of cardiomyopathy	about one year
Primary	identify patients whose at risk to develop cardiomyopathy	Using the high sensitive troponin with quantitative measurements as biomarker.	about one year
Secondary	molecular gene expression of troponin genes and ryanodine receptor in cardiomyopathy	quantitative correlation between the troponin genes and ryanodine receptor in early cardiomyopathy	same time frame ... about one year

External Links

•   Cancer Chemotherapy and Cardiac Arrhythmias: A Review