Cardiovascular Prevention Strategies in Elderly Patients With Cancer (CARTIER Clinical Trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intensive cardiovascular monitoring, No intervention.
- Who it may be relevant to
- Registry conditions: Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma), Elderly, Antineoplastic Agents, Cardiotoxicity. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cardiotoxicity in the Elderly. Comparative Clinical Trial Between Primary Versus Secondary Cardiovascular Prevention Strategies
Overview
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
Interventions
- Other Intensive cardiovascular monitoring
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 - 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; ECOG Performance status; cardiac patient care based on the onco-hematologist criteria
Primary outcome measures
- All-cause mortality [Time frame: Two (mid-term analysis) and five years of follow-up]
Secondary outcome measures (6)
- Oncological mortality [Time frame: Two and five years of follow-up]
- Cardiovascular mortality [Time frame: Two and five years of follow-up]
- Hospitalization [Time frame: Two and five years of follow-up]
- Hospitalization/emergency cardiovascular cause [Time frame: Two and five years of follow-up]
- Hospitalization/emergency cancer cause [Time frame: Two and five years of follow-up]
- Tumor recurrence or progression [Time frame: Two and five years of follow-up]
Eligibility criteria
Inclusion criteria
- > 65 years old
- Expected survival >1 year
- Colon cancer, breast cancer, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia, myeloma
- Signature on the informed consent
Exclusion criteria
- Patients included in clinical trials will be excluded if they interfere with the CARTIER follow-up protocol. If they do not interfere they can be included
- Patients who had received previous potentially cardiotoxic anticancer treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Spain · 14 centers
- Hospital Clínico Universitario de Santiago de Compostela — Santiago de Compostela
- Hospital de Galdakao-Usansolo — Galdakao
- Hospital Universitario Vall d´Hebron — Barcelona
- Hospital Universitario Reina Sofía — Córdoba
- Hospital Universitario de La Princesa — Madrid
- Hospital G. Universitario Gregorio Marañón — Madrid
- Hospital Universitario Ramón y Cajal — Madrid
- Hospital Universitario Fundación Jiménez Díaz — Madrid
- … and 6 more centers
Identifiers
NCT: NCT03711110 · CARTIER