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Recruiting NCT05366153

Risk-guided Disease managEment Plan to prevEnt CAD in Patients Treated With Previous Cancer

Observational Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coronary CT.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Risk-guided Disease managEment Plan to prevEnt CAD in Patients Treated With Previous Cancer (REDEEM-CAD)

Overview

REDEEM-CAD is a prospective multi-centre study of CAD risk evaluation and management in cancer survivors 40-70 years with chemotherapy or radiotherapy \>5 years ago.

Detailed description

REDEEM-CAD is a prospective multi-centre study in which a process of evaluating the risk of coronary artery disease is studied in cancer survivors 40-70 years with chemotherapy or radiotherapy \>5 years ago. The efficacy of this CAD risk evaluation will be compared with the broad community in two existing studies - CAUGHT-CAD and EDCAD. This unique Screening/Management Plan (SMP) has 2 components; 1) A novel clinical and imaging-based screening algorithm to select those most likely to develop coronary artery disease, 2) A clinical review to ensure optimal risk factor control and cardio protection.

Follow-up of treated patients will continue for an average of 36 months, with clinic reviews at 12, 24 and 36 months. The results will define the prevalence of subclinical coronary artery disease, and the feasibility and the efficacy of the SMP.

Interventions

  • Diagnostic test Coronary CT
    Screening/Management Plan

Primary outcome measures

  • Proportion of evaluated patients who should undergo CAD prevention [Time frame: 3 years]
Secondary outcome measures (3)
  • Proportion with critical CAD [Time frame: 3 years]
  • Proportion at intermediate clinical risk [Time frame: 3 years]
  • Statin responsiveness [Time frame: 3 year follow-up]

Eligibility criteria

Inclusion criteria

A history of cancer >5 y ago associated with potential cardiotoxicity from chemotherapy and/or radiotherapy (chiefly survivors of breast cancer, Hodgkin's lymphoma and prostate cancer).

Exclusion criteria

  • Unable to provide written informed consent to participate in this study
  • Known coronary artery disease at recruitment
  • History of previous coronary artery disease
  • Inability to acquire interpretable CT images
  • Contraindications/Intolerance to or already taking statin therapy
  • Oncologic (or other) life expectancy <12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Australia · 2 centers
  • Tom Marwick — Hobart
  • Baker Heart and Diabetes Institute — Melbourne

Publications

  • Soh CH, Smith J, Shrestha S, Nolan M, Wong J, Nerlekar N, Marwick TH. Screening for coronary artery disease among cancer survivors: rationale and design of the REDEEM-CAD study. Cardiooncology. 2025 Feb 4;11(1):10. doi: 10.1186/s40959-025-00308-7. PMID 39905553

Identifiers

NCT: NCT05366153 · 134-22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗