Cardiovascular Toxicity Induced by Antitumoral Drugs: Risk Assessment and Early Diagnosis. CARDIOTOX Registry
1 other identifier
observational
3,400
1 country
1
Brief Summary
The study is multicenter, post-authorization, observational and ambispective
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at 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
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 10, 2014
CompletedFirst Posted
Study publicly available on registry
January 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedJanuary 17, 2014
January 1, 2014
5.4 years
January 10, 2014
January 15, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Change in CARDIOTOXICITY DEVELOPMENT RISK SCORE
Risk of cardiovascular toxicity by antitumoral agents is multifactorial. * Clinical heart failure * Asymptomatic ventricular dysfunction * Elevated biomarkers * Severe arrhythmias * Myocardial ischemia * Other cardiac events
21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
change in EARLY DETECTION OF CARDIOTOXICITY
Early recognition of cardiotoxicity can help determine whether to continue treatment with a particular type of drug and set up preventive treatments. * Demographic variables for study inclusion * Clinical symptoms of cardiac disease * EKG * Transthoracic echocardiogram * Biological markers: Troponin I (cTnI), NTproBNP * Oncological variables: Diagnosis and cancer location, Drugs
21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
Secondary Outcomes (9)
Incidence of cardiovascular toxicity in its different forms
2 years
Incidence of cardiovascular toxicity in relation to the cumulative dose
21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
•Incidence of cardiovascular toxicity in relation to the kind of antitumor agent
21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
•Analyze the sensitivity and specificity of EKG changes regarding new changes in biomarkers, clinical and echocardiographic parameters
21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
Analyze whether alterations of biological markers predate clinical, echocardiographic and functional parameters
21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years
- +4 more secondary outcomes
Study Arms (1)
Patient under study condition
Patient under study condition
Eligibility Criteria
A case is defined as a patient on treatment (started or programmed, regardless of previous treatments or prior radiotherapy) with the following target antineoplastic agents: * Alkylating agents * Antimicrotubule agents * Vinca alkaloids * Monoclonal Antibodies * Antimetabolites * Anthracyclines * Angiogenesis inhibitors * Interleukins * Small molecule tyrosine kinase inhibitors * Other antineoplastic agents
You may qualify if:
- Patients\> 18 years with indicated antitumor chemotherapy.
- Estimated survival ≥ 6 months
- No oxygen dependence
- No contraindication for taking the study target antitumor agents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
La pAz University Hospital
Madrid, Madrid, 28046, Spain
Related Publications (1)
Caro-Codon J, Lopez-Fernandez T, Alvarez-Ortega C, Zamora Aunon P, Rodriguez IR, Gomez Prieto P, Buno Soto A, Canales Albendea M, Albaladejo A, Mediavilla G, Feliu Batlle J, Rodriguez Fraga O, Martinez Monzonis A, Gonzalez-Costello J, Serrano Antolin JM, Cadenas Chamorro R, Gonzalez-Juanatey JR, Lopez-Sendon J; CARDIOTOX registry investigators. Cardiovascular risk factors during cancer treatment. Prevalence and prognostic relevance: insights from the CARDIOTOX registry. Eur J Prev Cardiol. 2022 May 6;29(6):859-868. doi: 10.1093/eurjpc/zwaa034.
PMID: 33624069DERIVED
Related Links
Biospecimen
whole blood
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Luis Lopez-Sendon
La Paz University Hospital- Chief of Cardiology Department
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2014
First Posted
January 17, 2014
Study Start
July 1, 2011
Primary Completion
December 1, 2016
Last Updated
January 17, 2014
Record last verified: 2014-01