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Spots Global Cancer Trial Database for Cardiovascular Prevention Strategies in Elderly Patients With Cancer (CARTIER Clinical Trial)

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 65 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

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