CardiotoxicityCARTIERNCT03981588
Cardiotoxicity in the Elderly
An observational study of Cardiotoxicity and Elderly, run by AORTICA Group at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiotoxicity, Elderly, Cardiac Magnetic Resonance
- What is being tested?
- Imaging studies
- How many people
- 110 participants
- Where
- 2 sitesSpain
- Study dates
- Mar 2015to Mar 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients with newly diagnosed cancer initiating antisudoral treatment
Who may be able to join
- newly diagnosed cancer initiating antisudoral treatment
- capability to sign the informed consent
- capability to realize 6 minutes walking test
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario de Salamanca
Salamanca, 37002
Pedro Dorado
Salamanca, 37007
About this study
Official title: 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
Read the 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.
- Conditions
- Cardiotoxicity, Elderly, Cardiac Magnetic Resonance
- Being tested
- Imaging studies
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging studiesOther
Patients will undergo different imaging and clinical follow-up procedures to run out cardiotoxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiotoxicity
53% as the lower limit of ejection fraction regardless of gender
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study startMar 2015
- Primary completionDec 2016
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- AORTICA Group
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Responsible party
- Principal investigator, Pedro L Sanchez, AORTICA Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981588
- Sponsor's protocol ID
- PIE14/00066
- Acronym
- CARTIER
- Status last verified
- Jun 2019
- First submitted
- 6 Jun 2019
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARDIOTOXICITY IN THE ELDERLY
- ClinicalTrials.gov ID
- NCT03981588
- Acronym / sponsor ID
- CARTIER / PIE14/00066
- Conditions
- Cardiotoxicity, Elderly, Cardiac Magnetic Resonance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- AORTICA GroupUniversity, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2022 (estimated)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients with newly diagnosed cancer initiating antisudoral treatment
Key inclusion criteria (3 listed)
- newly diagnosed cancer initiating antisudoral treatment
- capability to sign the informed consent
- capability to realize 6 minutes walking test
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging studiesPatients will undergo different imaging and clinical follow-up procedures to run out cardiotoxicity | Other | – |
Primary outcome
Incidence of cardiotoxicity
Time frame: 5 years
53% as the lower limit of ejection fraction regardless of gender
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiotoxicity and Elderly, run by AORTICA Group at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiotoxicity (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.