Cardiotoxicity in the Elderly
CARTIER
CARDIOTOXICITY IN THE ELDERLY
1 other identifier
observational
110
1 country
2
Brief Summary
CARTIER (Cardiotoxicity in the elderly) is a prospective cohort study of newly diagnosed elderly cancer patients equal or greater than 65 years of age conduced in one tertiary center (Hospital Universitario de Salamanca at Spain. The study is academically funded in its integrity by The Instituto de Salud Carlos III (Spanish Ministry of Science, Innovation and Universities). The investigators of the study are the only responsible for the study design, data collection, and data interpretation. All study participants provide written informed consent. All enrolled patients will undergo serial surveys, 6-minutes walking test (6MWT), electrocardiogram, echocardiogram, blood samples, CMR, physical examinations and multidisciplinary clinical evaluations; before each chemotherapy cycle and at 3, 6, 9 and 12 months, 3 years and 5 years after finalization of chemotherapy, except for MRI that will be performed before 1st, 3rd, 5th cycles and at 3, 6, 9,12 months, 3 years and 5 years after chemotherapy ending
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2015
Longer than P75 for all trials
2 active sites
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
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 6, 2019
CompletedFirst Posted
Study publicly available on registry
June 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedMay 27, 2020
June 1, 2019
1.8 years
June 6, 2019
May 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of cardiotoxicity
53% as the lower limit of ejection fraction regardless of gender
5 years
Interventions
Patients will undergo different imaging and clinical follow-up procedures to run out cardiotoxicity
Eligibility Criteria
Elderly patients with newly diagnosed cancer initiating antisudoral treatment
You may qualify if:
- newly diagnosed cancer initiating antisudoral treatment
- capability to sign the informed consent
- capability to realize 6 minutes walking test
You may not qualify if:
- previous chemotherapy
- contraindications to undergo cardiac magnetic resonance (CMR)
- enrollment in onco-hematologist current clinical-trials
- clinical situation making difficult the realization of the proposed examinations or the course of chemotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AORTICA Grouplead
- Instituto de Investigación Biomédica de Salamancacollaborator
Study Sites (2)
Hospital Universitario de Salamanca
Salamanca, 37002, Spain
Pedro Dorado
Salamanca, 37007, Spain
Biospecimen
Blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Cardiology Department
Study Record Dates
First Submitted
June 6, 2019
First Posted
June 11, 2019
Study Start
March 1, 2015
Primary Completion
December 1, 2016
Study Completion
March 1, 2022
Last Updated
May 27, 2020
Record last verified: 2019-06