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

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ClinicalTrials.gov Identifier: NCT03381014
Recruitment Status : Not yet recruiting
First Posted : December 21, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Mostafa Mahmoud Morsy, Assiut University

Brief 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


Condition or disease Intervention/treatment
Chemotherapy Effect Drug: Chemotherapy, Cancer, Anthracyclines

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. early detection of cardiomyopathy [ Time Frame: about one year ]
    using speckle tracking echo to early diagnosis of cardiomyopathy

  2. identify patients whose at risk to develop cardiomyopathy [ Time Frame: about one year ]
    Using the high sensitive troponin with quantitative measurements as biomarker.


Secondary Outcome Measures :
  1. molecular gene expression of troponin genes and ryanodine receptor in cardiomyopathy [ Time Frame: same time frame ... about one year ]
    quantitative correlation between the troponin genes and ryanodine receptor in early cardiomyopathy



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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patient between the age of 30-50yr who will receive chemotherapy
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381014


Contacts
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Contact: Mostafa M Morsy, MD +201096955959 Mostafa_corono@yahoo.com
Contact: Hatem A helmy, MD +201005212162 hatem19652007@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: yehia T kishk, MD cardiology department
Principal Investigator: Mohamed K Koriem, MD cardiology department
Principal Investigator: Naglaa K Idriss, MD biochemistry department

Additional Information:
Publications of Results:
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Responsible Party: Mostafa Mahmoud Morsy, doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03381014     History of Changes
Other Study ID Numbers: speckle echo in cardiomyopathy
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases