NCT03381014

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 21, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

December 21, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

December 12, 2017

Last Update Submit

December 17, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • early detection of cardiomyopathy

    using speckle tracking echo to early diagnosis of cardiomyopathy

    about one year

  • identify patients whose at risk to develop cardiomyopathy

    Using the high sensitive troponin with quantitative measurements as biomarker.

    about one year

Secondary Outcomes (1)

  • molecular gene expression of troponin genes and ryanodine receptor in cardiomyopathy

    same time frame ... about one year

Interventions

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

Also known as: speckle tracking Echo

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Interventions

Anthracyclines

Intervention Hierarchy (Ancestors)

NaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • yehia T kishk, MD

    cardiology department

    STUDY CHAIR
  • Mohamed K Koriem, MD

    cardiology department

    PRINCIPAL INVESTIGATOR
  • Naglaa K Idriss, MD

    biochemistry department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa M Morsy, MD

CONTACT

Hatem A helmy, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

December 12, 2017

First Posted

December 21, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

August 1, 2019

Last Updated

December 21, 2017

Record last verified: 2017-12