Cardiotoxicity in the Elderly (CARTIER)

CARDIOTOXICITY IN THE ELDERLY

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

Study Overview

• Status: Unknown
• Conditions: Elderly; Cardiotoxicity; Cardiac Magnetic Resonance
• Intervention / Treatment: Other: Imaging studies

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.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Spain
  • Salamanca, Spain, 37002
    • Hospital Universitario de Salamanca
  • Salamanca, Spain, 37007
    • Pedro Dorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Elderly patients with newly diagnosed cancer initiating antisudoral treatment

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of cardiotoxicity	53% as the lower limit of ejection fraction regardless of gender	5 years

Collaborators and Investigators

• Sponsor: AORTICA Group
• Collaborators: Instituto de Investigación Biomédica de Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 8, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Cardiotoxicity
• Other Study ID Numbers: PIE14/00066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No