Cardiovascular Prevention Strategies in Elderly Patients With Cancer (CARTIER Clinical Trial)
- Conditions
- Antineoplastic AgentsCardiotoxicityCancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)Elderly
- Interventions
- Other: No interventionOther: Intensive cardiovascular monitoring
- Registration Number
- NCT03711110
- Lead Sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 514
- > 65 years old
- Expected survival >1 year
- Colon cancer, breast cancer, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia, myeloma
- Signature on the informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Secondary prevention strategy (control) No intervention Current clinical practice: cardiac care is based on the onco-hematologist criteria. Primary prevention strategy Intensive cardiovascular monitoring Intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care.
- Primary Outcome Measures
Name Time Method All-cause mortality Two (mid-term analysis) and five years of follow-up Cumulative incidence of all-cause mortality
- Secondary Outcome Measures
Name Time Method Tumor recurrence or progression Two and five years of follow-up Incidence of tumoral recurrence or progression
Oncological mortality Two and five years of follow-up Cumulative incidence of oncological mortality
Cardiovascular mortality Two and five years of follow-up Cumulative incidence of cardiovascular mortality
Hospitalization Two and five years of follow-up Cumulative incidence of hospitalization
Hospitalization/emergency cardiovascular cause Two and five years of follow-up Cumulative incidence of hospitalization and/or emergency care for cardiovascular cause
Hospitalization/emergency cancer cause Two and five years of follow-up Cumulative incidence of hospitalization and/or emergency care for cancer cause
Trial Locations
- Locations (14)
Hospital Universitario Vall d´Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Complejo Asistencial Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitario Río Hortega
🇪🇸Valladolid, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital de Galdakao-Usansolo
🇪🇸Galdakao, Vizcaya, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Madrid, Spain
Hospital G. Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Clínico Universitario de Santiago de Compostela
🇪🇸Santiago De Compostela, A Coruña, Spain