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

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT05366153
• Lead Sponsor: Baker Heart and Diabetes Institute

Brief Summary

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.

Study Timeline

• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Status Verified: 2023-09
• Study Start: 2023-10-18
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 748

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of evaluated patients who should undergo CAD prevention	3 years	High clinical risk, or intermediate risk with CAC score \>0

Secondary Outcome Measures

Name	Time	Method
Proportion with critical CAD	3 years	Coronary stenosis \>70% by CT coronary angiogram
Statin responsiveness	3 year follow-up	Change in plaque volume
Proportion at intermediate clinical risk	3 years	Intermediate clinical risk (0.8-2.0% annualized risk by Pooled Cohort Equation)

Trial Locations

Locations (2)

Tom Marwick; 🇦🇺 Hobart, Tasmania, Australia

Baker Heart and Diabetes Institute; 🇦🇺 Melbourne, Victoria, Australia