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Brief Title: Cardiovascular Prevention Strategies in Elderly Patients With Cancer (CARTIER Clinical Trial)
Official Title: Cardiotoxicity in the Elderly. Comparative Clinical Trial Between Primary Versus Secondary Cardiovascular Prevention Strategies
Study ID: NCT03711110
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:
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Clínico Universitario de Santiago de Compostela, Santiago De Compostela, A Coruña, Spain
Hospital de Galdakao-Usansolo, Galdakao, Vizcaya, Spain
Hospital Universitario Vall d´Hebron, Barcelona, , Spain
Hospital Universitario Reina Sofía, Córdoba, , Spain
Hospital Universitario de La Princesa, Madrid, , Spain
Hospital G. Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Puerta de Hierro, Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Málaga, , Spain
Complejo Asistencial Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Universitario Río Hortega, Valladolid, , Spain
Name: Pedro L Sánchez, Ph. D.
Affiliation: IBSAL-Instituto de Investigación Biomédica de Salamanca
Role: STUDY_DIRECTOR
Name: Ana Martín-García, Ph. D.
Affiliation: IBSAL-Instituto de Investigación Biomédica de Salamanca
Role: STUDY_DIRECTOR