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Cardiotoxicity in the Elderly (CARTIER)

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ClinicalTrials.gov Identifier: NCT03981588
Recruitment Status : Active, not recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
Instituto de Investigación Biomédica de Salamanca
Information provided by (Responsible Party):
Pedro L Sanchez, AORTICA Group

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

Condition or disease Intervention/treatment
Cardiotoxicity Elderly Cardiac Magnetic Resonance 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: CARDIOTOXICITY IN THE ELDERLY
Actual Study Start Date : March 2015
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : March 2020

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


Primary Outcome Measures :
  1. Incidence of cardiotoxicity [ Time Frame: 5 years ]
    53% as the lower limit of ejection fraction regardless of gender


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elderly patients with newly diagnosed cancer initiating antisudoral treatment
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981588


Locations
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Spain
Hospital Universitario de Salamanca
Salamanca, Spain, 37002
Pedro Dorado
Salamanca, Spain, 37007
Sponsors and Collaborators
AORTICA Group
Instituto de Investigación Biomédica de Salamanca

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Responsible Party: Pedro L Sanchez, Head of the Cardiology Department, AORTICA Group
ClinicalTrials.gov Identifier: NCT03981588     History of Changes
Other Study ID Numbers: PIE14/00066
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries