Cardiotoxicity in the Elderly

Elderly Clinical Trial

— CARTIER  

Official title:

CARDIOTOXICITY IN THE ELDERLY

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03981588
• Other study ID #: PIE14/00066
• Status: Active, not recruiting
• Start date: March 2015
• Est. completion date: March 2022

Study information

• Verified date: June 2019
• Source: AORTICA Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: March 2022
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Magnetic Resonance
• Cardiotoxicity
• Elderly

Intervention

Other:
• Imaging studies
Patients will undergo different imaging and clinical follow-up procedures to run out cardiotoxicity

Locations

Country	Name	City	State
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Pedro Dorado	Salamanca

Sponsors (2)

Lead Sponsor	Collaborator
AORTICA Group	Instituto de Investigación Biomédica de Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cardiotoxicity	53% as the lower limit of ejection fraction regardless of gender	5 years