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Cardiotoxicity in the Elderly (CARTIER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date June 6, 2019
First Posted Date June 11, 2019
Last Update Posted Date June 11, 2019
Actual Study Start Date March 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 8, 2019)
Incidence of cardiotoxicity [ Time Frame: 5 years ]
53% as the lower limit of ejection fraction regardless of gender
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiotoxicity in the Elderly
Official Title CARDIOTOXICITY IN THE ELDERLY
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
Blood samples
Sampling Method Non-Probability Sample
Study Population Elderly patients with newly diagnosed cancer initiating antisudoral treatment
Condition
  • Cardiotoxicity
  • Elderly
  • Cardiac Magnetic Resonance
Intervention Other: Imaging studies
Patients will undergo different imaging and clinical follow-up procedures to run out cardiotoxicity
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: June 8, 2019)
110
Original Actual Enrollment Same as current
Estimated Study Completion Date March 2020
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03981588
Other Study ID Numbers PIE14/00066
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Pedro L Sanchez, AORTICA Group
Study Sponsor AORTICA Group
Collaborators Instituto de Investigación Biomédica de Salamanca
Investigators Not Provided
PRS Account AORTICA Group
Verification Date June 2019