Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT03711110

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

Led by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · Updated on 2025-03-21

514

Participants Needed

14

Research Sites

330 weeks

Total Duration

On this page

Sponsors

F

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Lead Sponsor

I

Instituto de Investigación Biomédica de Salamanca

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 65 years
  • Expected survival longer than 1 year
  • Diagnosed with colon cancer, breast cancer, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia, or myeloma
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Participation in clinical trials that interfere with CARTIER follow-up protocol
  • Prior treatment with potentially cardiotoxic anticancer therapies

AI-Screening

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Trial Site Locations

Total: 14 locations

1

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain, 15706

Not Yet Recruiting

2

Hospital de Galdakao-Usansolo

Galdakao, Vizcaya, Spain, 48960

Not Yet Recruiting

3

Hospital Universitario Vall d´Hebron

Barcelona, Spain, 08035

Not Yet Recruiting

4

Hospital Universitario Reina Sofía

Córdoba, Spain, 14004

Not Yet Recruiting

5

Hospital Universitario de La Princesa

Madrid, Spain, 28006

Not Yet Recruiting

6

Hospital G. Universitario Gregorio Marañón

Madrid, Spain, 28009

Not Yet Recruiting

7

Hospital Universitario Ramón y Cajal

Madrid, Spain, 28034

Not Yet Recruiting

8

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain, 28040

Not Yet Recruiting

9

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Not Yet Recruiting

10

Hospital Universitario Puerta de Hierro

Madrid, Spain, 28222

Not Yet Recruiting

11

Hospital Universitario Virgen de la Victoria

Málaga, Spain, 29010

Not Yet Recruiting

12

Complejo Asistencial Universitario de Salamanca

Salamanca, Spain, 37007

Actively Recruiting

13

Hospital Universitario Virgen del Rocío

Seville, Spain, 41013

Not Yet Recruiting

14

Hospital Universitario Río Hortega

Valladolid, Spain, 47012

Not Yet Recruiting

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Research Team

P

Pedro L Sánchez, Ph. D.

CONTACT

A

Ana Martín-García, Ph. D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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