An interventional study of Intensive cardiovascular monitoring and No intervention in Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma), Elderly and Antineoplastic Agents, sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León. Recruiting at 14 sites in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · Not applicable, Interventional, and Prevention
The CARTIER study is a randomized, multicenter, open-label clinical trial comparing, in elderly patients with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies: primary (intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care) vs. secondary (current clinical practice where intensive cardiovascular monitoring is not routinely performed and cardiotoxicity patient care is based on the onco-hematologist criteria).
The primary endpoint is to determine whether this primary prevention englobing cardiovascular monitoring plus intensive multidisciplinary management is superior to the current clinical practice in reducing all cause mortality.
Other secondary objectives of the study are to analyze the impact of this intensive cardiovascular monitoring strategy on the incidence of cardiovascular mortality, oncological mortality, hospitalization and/or urgent care due to cardiovascular complications, hospitalization and/or urgent oncological care due to cancer complications, tumor progression and cost-effectiveness analysis.
A total of 514 patients ≥ 65 years old diagnosed with any of the following onco-hematological cancers, colon, breast, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia or myeloma, undergoing standardized anti-tumoral treatment, will be recruited.
The incidence of primary and secondary outcomes will be measured at 2 and 5 years
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 514 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care.
Other: Intensive cardiovascular monitoring
Current clinical practice: cardiac care is based on the onco-hematologist criteria.
Other: No intervention
Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years). Assessment protocol: Anamnesis and physical examination; EKG; Echocardiogram; Biomarkers (troponin and natriuretic peptide); Structured counselling on healthy cardiac practices; Treatment optimization of cardiovascular risk factors and heart diseases; Quality of life (ECOG Performance status and Minnesota questionnaires); Interaction and management of patient care by the cardio-onco-hematology team. Moreover, cardiac MRI in centers participating in the CARTIER-MR sub-study.
Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years). Assessment protocol: Anamnesis and physical examination; ECOG Performance status; cardiac patient care based on the onco-hematologist criteria
All-cause mortality
Cumulative incidence of all-cause mortality
Time frame: Two (mid-term analysis) and five years of follow-up
Oncological mortality
Cumulative incidence of oncological mortality
Time frame: Two and five years of follow-up
Cardiovascular mortality
Cumulative incidence of cardiovascular mortality
Time frame: Two and five years of follow-up
Hospitalization
Cumulative incidence of hospitalization
Time frame: Two and five years of follow-up
Hospitalization/emergency cardiovascular cause
Cumulative incidence of hospitalization and/or emergency care for cardiovascular cause
Time frame: Two and five years of follow-up
Hospitalization/emergency cancer cause
Cumulative incidence of hospitalization and/or emergency care for cancer cause
Time frame: Two and five years of follow-up
Tumor recurrence or progression
Incidence of tumoral recurrence or progression
Time frame: Two and five years of follow-up
Ran from Aug 2019 to primary completion in Aug 2024, 60 months.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's 60 months is above that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León