Evaluation and Management of Cardio Toxicity in Oncologic Patients
1 other identifier
observational
1,000
1 country
1
Brief Summary
The survival rate of cancer patients has greatly increased over the past decades' mainly due to early detection and the use of new medications with higher doses and combined protocols. This achievement comes with the price of cardio toxicity, leading to cardiac dysfunction ranged from transient asymptomatic left ventricular dysfunction to cardiac death. In the long term, the risk of death from cardiovascular causes exceeds that of tumor recurrence for many types of cancer. As a result of the increasing number of long-term cancer survivors the magnitude of this problem is growing. Early identification of cardio toxicity can be identified by clinical follow-up and the use of electrocardiography, cardiac biomarkers (Troponin, brain natriuretic peptide) and echocardiogram. Past studies imply that the addition of angiotensin-converting-enzyme inhibitor (ACE inhibitor) and beta blockers to the patient's treatment may prevent the development of cardiac dysfunction. However, currently there are no specific or clear guidelines for the follow-up and management of cardio-toxicity in cancer patients. The aim of the study: To try to identify who are the patients at increased risk for developing cardio toxicity, by follow up of clinical evaluation, cardiac biomarkers and echocardiogram examination, in purpose of early diagnosis, management and prevention of cardiac events. For achieving this the investigators will build a registry which will include all the oncologic patients going an evaluation in the cardio-oncology clinic in the Tel Aviv Medical Center .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2016
Longer than P75 for all trials
1 active site
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
June 15, 2016
CompletedFirst Posted
Study publicly available on registry
June 29, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
February 2, 2022
February 1, 2022
14.3 years
June 15, 2016
February 1, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
ECho-global strain
Predictor of reduction Ejection Fraction
2 years
Troponin (ng/ml)
Predictor of reduction Heart failure
2 years
ACE inhibitor and beta blocker treatment
estimating the effect of ACE inhibitors and beta blockers preventive treatment for heart failure due to chemotherapy.
2 years
BNP (PG/ML)
Predictor of reduction Heart failure
2 years
Study Arms (1)
Heart failure
Evaluating the cardio toxicity effect of chemotherapy and radiation and estimating the effect of ACE inhibitors and beta blockers in the prevention of heart failure.
Interventions
Evaluating the cardio toxicity effect of chemotherapy and radiation and estimating the effect of ACE inhibitors and beta blockers in the prevention of heart failure.
Evaluating the cardio toxicity effect of chemotherapy and radiation and estimating the effect of ACE inhibitors and beta blockers in the prevention of heart failure.
Eligibility Criteria
The study will be composed of two groups: 1. The retrospective group analysis will include all oncologic patients who were evaluated in the cardio-oncology clinic between 01 January 2014 until 31 May 2016. 2. The prospective group will include all oncologic patients who will be evaluated in the cardio-oncology clinic from 01 June 2016 onward. The patients will sign an informed consent form.
You may qualify if:
- All patient evaluated in the cardio-oncology clinic in Tel Aviv MC
You may not qualify if:
- In the prospective Study - patients not sign an informed consent form.
- Patient reluctance to continue the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tel Aviv Medical Center
Tel Aviv, Israel
Related Publications (1)
Shamai S, Rozenbaum Z, Merimsky O, Derakhshesh M, Moshkovits Y, Arnold J, Topilsky Y, Arbel Y, Laufer-Perl M. Cardio-toxicity among patients with sarcoma: a cardio-oncology registry. BMC Cancer. 2020 Jun 30;20(1):609. doi: 10.1186/s12885-020-07104-9.
PMID: 32605637DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Udi Chorin, MD
Tel Aviv MC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Udi Chorin MD
Study Record Dates
First Submitted
June 15, 2016
First Posted
June 29, 2016
Study Start
August 1, 2016
Primary Completion (Estimated)
November 30, 2030
Study Completion (Estimated)
December 31, 2031
Last Updated
February 2, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share