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

December 17, 2017 updated by: Mostafa Mahmoud Morsy, Assiut University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cancer patient between the age of 30-50yr who will receive chemotherapy

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early detection of cardiomyopathy
Time Frame: about one year
using speckle tracking echo to early diagnosis of cardiomyopathy
about one year
identify patients whose at risk to develop cardiomyopathy
Time Frame: about one year
Using the high sensitive troponin with quantitative measurements as biomarker.
about one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
same time frame ... about one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: yehia T kishk, MD, Cardiology Department
  • Principal Investigator: Mohamed K Koriem, MD, Cardiology Department
  • Principal Investigator: Naglaa K Idriss, MD, Biochemistry department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2018

Primary Completion (ANTICIPATED)

January 1, 2019

Study Completion (ANTICIPATED)

August 1, 2019

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 17, 2017

First Posted (ACTUAL)

December 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 21, 2017

Last Update Submitted That Met QC Criteria

December 17, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • speckle echo in cardiomyopathy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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