Cardiovascular Prevention Strategies in Elderly Patients With Cancer (CARTIER Clinical Trial)

Last updated: March 18, 2025
Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer/tumors

Leukemia

Bone Neoplasm

Treatment

Intensive cardiovascular monitoring

No intervention

Clinical Study ID

NCT03711110
CARTIER
  • Ages > 65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • > 65 years old

  • Expected survival >1 year

  • Colon cancer, breast cancer, lymphoma, chronic lymphoma leukemia, chronic myeloidleukemia, myeloma

  • Signature on the informed consent

Exclusion

Exclusion Criteria:

  • Patients included in clinical trials will be excluded if they interfere with theCARTIER follow-up protocol. If they do not interfere they can be included

  • Patients who had received previous potentially cardiotoxic anticancer treatment

Study Design

Total Participants: 514
Treatment Group(s): 2
Primary Treatment: Intensive cardiovascular monitoring
Phase:
Study Start date:
August 02, 2019
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago De Compostela, A Coruña 15706
    Spain

    Site Not Available

  • Hospital de Galdakao-Usansolo

    Galdakao, Vizcaya 48960
    Spain

    Site Not Available

  • Hospital Universitario Vall d´Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofía

    Córdoba, 14004
    Spain

    Site Not Available

  • Hospital G. Universitario Gregorio Marañón

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Madrid, 28222
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario de La Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario Río Hortega

    Valladolid, 47012
    Spain

    Site Not Available

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