Chemotherapy EffectNCT03381014
Early Detection of Cardiomyopathy by Speckle Echo, High Sensitive Troponin and Cardiac Ryanodine Receptors
An observational study of Chemotherapy Effect, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Chemotherapy Effect
- What is being tested?
- Chemotherapy, Cancer, Anthracyclines
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Cancer patient between the age of 30-50yr who will receive chemotherapy
Who may be able to join
- all Newly diagnosed cancer patients with who will receive Anthracycline based regimen chemotherapy
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
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
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
Read the 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.
- Conditions
- Chemotherapy Effect
- Being tested
- Chemotherapy, Cancer, Anthracyclines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy, Cancer, AnthracyclinesDrug
Also called speckle tracking Echo
follow up cardio-toxicity .... by speckle tracking echo and cardiac troponin
What is being measured
The primary outcome is the main question the study is designed to answer.
early detection of cardiomyopathy
using speckle tracking echo to early diagnosis of cardiomyopathy
Measured: about one year
identify patients whose at risk to develop cardiomyopathy
Using the high sensitive troponin with quantitative measurements as biomarker.
Measured: about one year
Secondary outcomes (1)
molecular gene expression of troponin genes and ryanodine receptor in cardiomyopathy
quantitative correlation between the troponin genes and ryanodine receptor in early cardiomyopathy
Measured: same time frame ... about one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy EffectStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mahmoud Morsy, Assiut University
- Investigators
- yehia T kishk, MD, Study chair, cardiology departmentMohamed K Koriem, MD, Principal investigator, cardiology departmentNaglaa K Idriss, MD, Principal investigator, biochemistry department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381014
- Sponsor's protocol ID
- speckle echo in cardiomyopathy
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 21 Dec 2017
- Results posted
- No
Publications
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.
PubMed 28660778Curigliano 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.
PubMed 26919165
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03381014
- Acronym / sponsor ID
- speckle echo in cardiomyopathy
- Conditions
- Chemotherapy Effect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Cancer patient between the age of 30-50yr who will receive chemotherapy
Key inclusion criteria (1 listed)
- all Newly diagnosed cancer patients with who will receive Anthracycline based regimen chemotherapy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapy, Cancer, AnthracyclinesAlso: speckle tracking Echofollow up cardio-toxicity .... by speckle tracking echo and cardiac troponin | Drug | – |
Primary outcome
early detection of cardiomyopathy
Time frame: about one year
using speckle tracking echo to early diagnosis of cardiomyopathy
identify patients whose at risk to develop cardiomyopathy
Time frame: about one year
Using the high sensitive troponin with quantitative measurements as biomarker.
1 secondary outcome
molecular gene expression of troponin genes and ryanodine receptor in cardiomyopathy
Time frame: same time frame ... about one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
- Results publication: PubMed 28660778Henning 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.
- Results publication: PubMed 26919165Curigliano 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.
- Cancer Chemotherapy and Cardiac Arrhythmias: A ReviewLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yehia T kishk, MD study chair
cardiology department
Mohamed K Koriem, MD principal investigator
cardiology department
Naglaa K Idriss, MD principal investigator
biochemistry department
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy Effect, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa M Morsy, MD (+201096955959, Mostafa_corono@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early detection of cardiomyopathy (time frame: about one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03381014, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2017.