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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: Coronary CT

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 Type: Observational
• Enrollment (Estimated): 748

Contacts and Locations

• Study Contact: Name: Tom Marwick, MBBS,PhD,MPH; Phone Number: +61 3 8532 1550; Email: tom.marwick@baker.edu.au
• Study Contact Backup: Name: Lisa Riddell; Phone Number: +61 3 8532 1550; Email: lisa.riddell@baker.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Cancer survivors 40-70 years with chemotherapy or radiotherapy >5 years ago

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Survivor Screening/Management Plan; In cancer survivors; A novel clinical and CT imaging-based screening algorithm to select those most likely to develop coronary artery disease,; A clinical review to ensure optimal risk factor control and cardiac protection.	Diagnostic test: Coronary CT; Screening/Management Plan
Non-cancer Screening/Management Plan; In matched non-cancer patients (from EDCAD trial); A novel clinical and CT imaging-based screening algorithm to select those most likely to develop coronary artery disease,; A clinical review to ensure optimal risk factor control and cardiac protection.	Diagnostic test: Coronary CT; Screening/Management Plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of evaluated patients who should undergo CAD prevention	High clinical risk, or intermediate risk with CAC score >0	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baker Heart and Diabetes Institute
• Collaborators: The Alfred; Peter MacCallum Cancer Centre, Australia; Menzies Institute for Medical Research; Northern Hospital, Australia; Western Health, Australia
• Investigators: Principal Investigator: Tom Marwick, MBBS,PhD,MPH, Baker Heart and Diabetes Institute

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 134-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No