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

Not Applicable

Recruiting

• Conditions: Antineoplastic Agents; Cardiotoxicity; Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma); Elderly

• 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

Study Timeline

• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-17
• Study First Posted: 2018-10-18
• Study Start: 2019-08-02
• Primary Completion: 2024-08-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 514

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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
Tumor recurrence or progression	Two and five years of follow-up	Incidence of tumoral recurrence or progression

Trial Locations

Locations (14)

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

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