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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: Coronary CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Survivor Screening/Management Plan<br>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<br>* Screening/Management Plan<br>|
| Non-cancer Screening/Management Plan<br>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<br>* Screening/Management Plan<br>|

What is the study measuring?
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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 |