Clinical trial NCT03981588: Cardiotoxicity in the Elderly
Official title: CARDIOTOXICITY IN THE ELDERLY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiotoxicity
Elderly
Cardiac Magnetic Resonance
Lead sponsor: AORTICA Group
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biomédica de Salamanca
First posted: 2019-06-11
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients with newly diagnosed cancer initiating antisudoral treatment

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

Detailed description: Surveys completion and examinations will be obtained at the same day: within 72 hours before each cycle of treatment or at 3, 6, 9, 12 months, 3 years and 5 years' follow-up after ending the whole antitumoral course of treatment. A fully dedicated research nurse will play a vital role in ensuring that the study run smoothly and that all participants will be safe and fully informed. Questionnaires completion and quality of life assessment will initially be performed followed by the 6MWT. Participants blood pressure measurement, electrocardiogram and echocardiogram will be then taken \>30 minutes after finishing the walking test. Blood sample extraction will be performed after echocardiography to finalize with cardiac magnetic resonance. A complete medical history, physical examination and evaluation of these examinations for each participant will be performed by a cardiologist at the cardio-oncology unit, where prevention and treatment protocols for cardiotoxicity will be applied and discussed in a multidisciplinary way with referral oncologists and hematologists before every cycle of treatment and after course of antitumoral ending follow-up.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed cancer initiating antisudoral treatment
* capability to sign the informed consent
* capability to realize 6 minutes walking test

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of cardiotoxicity
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Salamanca
country: Spain
facility: Pedro Dorado
Study officials:
References: