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

Coronary Artery Disease Clinical Trial

— REDEEM-CAD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05366153
• Other study ID #: 134-22
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: May 2026

Study information

• Verified date: September 2023
• Source: Baker Heart and Diabetes Institute
• Contact: Tom Marwick, MBBS,PhD,MPH
• Phone: +61 3 8532 1550
• Email: tom.marwick[@]baker.edu.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 748
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Diagnostic Test:
• Coronary CT
Screening/Management Plan

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Baker Heart and Diabetes Institute	Menzies Institute for Medical Research, Northern Hospital, Australia, Peter MacCallum Cancer Centre, Australia, The Alfred, Western Health, Australia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of evaluated patients who should undergo CAD prevention	High clinical risk, or intermediate risk with CAC score >0	3 years
Secondary	Proportion with critical CAD	Coronary stenosis >70% by CT coronary angiogram	3 years
Secondary	Proportion at intermediate clinical risk	Intermediate clinical risk (0.8-2.0% annualized risk by Pooled Cohort Equation)	3 years
Secondary	Statin responsiveness	Change in plaque volume	3 year follow-up