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

November 27, 2023 updated by: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Cardiotoxicity in the Elderly. Comparative Clinical Trial Between Primary Versus Secondary Cardiovascular Prevention Strategies

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

514

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitario Vall d´Hebron
        • Contact:
        • Principal Investigator:
          • Ignacio Ferreira-González, MD
      • Córdoba, Spain, 14004
        • Not yet recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
        • Principal Investigator:
          • Dolores Mesa, MD
      • Madrid, Spain, 28034
        • Not yet recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
        • Principal Investigator:
          • Ana Pardo-Sanz, MD
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Contact:
        • Principal Investigator:
          • Luis F Navarro-del-Amo, MD
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 de octubre
        • Contact:
        • Principal Investigator:
          • Carmen Jiménez-López-Guarch, MD
      • Madrid, Spain, 28006
        • Not yet recruiting
        • Hospital Universitario de la Princesa
        • Contact:
          • Fernando Alfonso-Manterola
          • Phone Number: +34 915 202 200
          • Email: falf@hotmail.com
        • Principal Investigator:
          • Fernando Alfonso-Manterola, Md
      • Madrid, Spain, 28009
        • Not yet recruiting
        • Hospital G. Universitario Gregorio Marañón
        • Contact:
        • Principal Investigator:
          • Eduardo Zatarain-Nicolás, MD
      • Madrid, Spain, 28222
        • Not yet recruiting
        • Hospital Universitario Puerta de Hierro
        • Contact:
        • Principal Investigator:
          • Cristina Mitroi, MD
      • Málaga, Spain, 29010
        • Not yet recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
        • Principal Investigator:
          • Juan J Gómez-Doblas, MD
      • Salamanca, Spain, 37007
        • Recruiting
        • Complejo Asistencial Universitario de Salamanca
        • Contact:
        • Principal Investigator:
          • Ana Martín-García, Ph. D.
        • Principal Investigator:
          • Pedro L Sánchez, Ph. D.
      • Sevilla, Spain, 41013
        • Not yet recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
        • Principal Investigator:
          • Gonzalo Baron-Esquivias, MD
      • Valladolid, Spain, 47012
        • Not yet recruiting
        • Hospital Universitario Río Hortega
        • Contact:
        • Principal Investigator:
          • Marina Revilla-Martínez, MD
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain, 15706
        • Not yet recruiting
        • Hospital Clinico Universitario de Santiago de Compostela
        • Contact:
        • Principal Investigator:
          • Pilar Mazón-Ramos, MD
    • Vizcaya
      • Galdakao, Vizcaya, Spain, 48960
        • Not yet recruiting
        • Hospital de Galdakao-Usansolo
        • Contact:
        • Principal Investigator:
          • Sonia Velasco, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary prevention strategy
Intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care.
Other: Intensive cardiovascular monitoring

Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years).

Assessment protocol: Anamnesis and physical examination; EKG; Echocardiogram; Biomarkers (troponin and natriuretic peptide); Structured counselling on healthy cardiac practices; Treatment optimization of cardiovascular risk factors and heart diseases; Quality of life (ECOG Performance status and Minnesota questionnaires); Interaction and management of patient care by the cardio-onco-hematology team. Moreover, cardiac MRI in centers participating in the CARTIER-MR sub-study.
Other: Secondary prevention strategy (control)
Current clinical practice: cardiac care is based on the onco-hematologist criteria.
Other: No intervention

Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years).

Assessment protocol: Anamnesis and physical examination; ECOG Performance status; cardiac patient care based on the onco-hematologist criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: Two (mid-term analysis) and five years of follow-up
Cumulative incidence of all-cause mortality
Two (mid-term analysis) and five years of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncological mortality
Time Frame: Two and five years of follow-up
Cumulative incidence of oncological mortality
Two and five years of follow-up
Cardiovascular mortality
Time Frame: Two and five years of follow-up
Cumulative incidence of cardiovascular mortality
Two and five years of follow-up
Hospitalization
Time Frame: Two and five years of follow-up
Cumulative incidence of hospitalization
Two and five years of follow-up
Hospitalization/emergency cardiovascular cause
Time Frame: Two and five years of follow-up
Cumulative incidence of hospitalization and/or emergency care for cardiovascular cause
Two and five years of follow-up
Hospitalization/emergency cancer cause
Time Frame: Two and five years of follow-up
Cumulative incidence of hospitalization and/or emergency care for cancer cause
Two and five years of follow-up
Tumor recurrence or progression
Time Frame: Two and five years of follow-up
Incidence of tumoral recurrence or progression
Two and five years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Instituto de Investigación Biomédica de Salamanca
Instituto de Salud Carlos III

Investigators

  • Study Director: Pedro L Sánchez, Ph. D., IBSAL-Instituto de Investigación Biomédica de Salamanca
  • Study Director: Ana Martín-García, Ph. D., IBSAL-Instituto de Investigación Biomédica de Salamanca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2019

Primary Completion (Estimated)

August 2, 2024

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

October 17, 2018

First Posted (Actual)

October 18, 2018

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARTIER

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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