REDEEM-CAD: Risk-guided Disease managEment Plan to prevEnt CAD in Patients Treated With Previous Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Proportion of evaluated patients who should undergo CAD prevention [3 years]
High clinical risk, or intermediate risk with CAC score >0
Secondary Outcome Measures
- Proportion with critical CAD [3 years]
Coronary stenosis >70% by CT coronary angiogram
- Proportion at intermediate clinical risk [3 years]
Intermediate clinical risk (0.8-2.0% annualized risk by Pooled Cohort Equation)
- Statin responsiveness [3 year follow-up]
Change in plaque volume
Eligibility Criteria
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:
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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
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Baker Heart and Diabetes Institute
- Western Health, Australia
- Northern Hospital, Australia
- Menzies Institute for Medical Research
- Peter MacCallum Cancer Centre, Australia
- The Alfred
Investigators
- Principal Investigator: Tom Marwick, MBBS,PhD,MPH, Baker Heart and Diabetes Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 134-22