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

NCT ID: NCT03381014

Last Updated: 2017-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-08-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Chemotherapy Effect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Chemotherapy, Cancer, Anthracyclines

follow up cardio-toxicity .... by speckle tracking echo and cardiac troponin

Intervention Type DRUG

Other Intervention Names

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speckle tracking Echo

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Mahmoud Morsy

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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yehia T kishk, MD

Role: STUDY_CHAIR

cardiology department

Mohamed K Koriem, MD

Role: PRINCIPAL_INVESTIGATOR

cardiology department

Naglaa K Idriss, MD

Role: PRINCIPAL_INVESTIGATOR

biochemistry department

Central Contacts

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Mostafa M Morsy, MD

Role: CONTACT

Phone: +201096955959

Email: [email protected]

Hatem A helmy, MD

Role: CONTACT

Phone: +201005212162

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 28660778 (View on PubMed)

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.

Reference Type RESULT
PMID: 26919165 (View on PubMed)

Related Links

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http://www.readcube.com/articles/10.1007/s40264-014-0258-4

Cancer Chemotherapy and Cardiac Arrhythmias: A Review

Other Identifiers

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speckle echo in cardiomyopathy

Identifier Type: -

Identifier Source: org_study_id