Clinical trial NCT05366153: Risk-guided Disease managEment Plan to prevEnt CAD in Patients Treated With Previous Cancer
Official title: Risk-guided Disease managEment Plan to prevEnt CAD in Patients Treated With Previous Cancer (REDEEM-CAD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
Collaborators: name: Western Health, Australia
name: Northern Hospital, Australia
name: Menzies Institute for Medical Research
name: Peter MacCallum Cancer Centre, Australia
name: The Alfred
First posted: 2022-05-09
Enrollment: 748
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer survivors 40-70 years with chemotherapy or radiotherapy \>5 years ago

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.

Eligibility 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:

* 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

Primary outcomes:
measure: Proportion of evaluated patients who should undergo CAD prevention
timeFrame: 3 years
Secondary outcomes:
measure: Proportion with critical CAD
timeFrame: 3 years
measure: Proportion at intermediate clinical risk
timeFrame: 3 years
measure: Statin responsiveness
timeFrame: 3 year follow-up
Other outcomes:
Locations:
city: Hobart
country: Australia
facility: Tom Marwick
state: Tasmania
city: Melbourne
country: Australia
facility: Baker Heart and Diabetes Institute
state: Victoria
Study officials:
affiliation: Baker Heart and Diabetes Institute
name: Tom Marwick, MBBS,PhD,MPH
role: PRINCIPAL_INVESTIGATOR
References: