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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05366153




Registration number
NCT05366153
Ethics application status
Date submitted
4/05/2022
Date registered
9/05/2022
Date last updated
22/08/2024

Titles & IDs
Public title
Risk-guided Disease managEment Plan to prevEnt CAD in Patients Treated With Previous Cancer
Scientific title
Risk-guided Disease managEment Plan to prevEnt CAD in Patients Treated With Previous Cancer (REDEEM-CAD)
Secondary ID [1] 0 0
134-22
Universal Trial Number (UTN)
Trial acronym
REDEEM-CAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Coronary CT

Survivor Screening/Management Plan - In cancer survivors;

1. A novel clinical and CT 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 cardiac protection.

Non-cancer Screening/Management Plan - In matched non-cancer patients (from EDCAD trial);

1. A novel clinical and CT 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 cardiac protection.


Diagnosis / Prognosis: Coronary CT
Screening/Management Plan
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of evaluated patients who should undergo CAD prevention
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Proportion with critical CAD
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Proportion at intermediate clinical risk
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Statin responsiveness
Timepoint [3] 0 0
3 year follow-up

Eligibility
Key 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).
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
748
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS,VIC
Recruitment hospital [1] 0 0
Tom Marwick - Hobart
Recruitment hospital [2] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
7000 - Hobart
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Western Health, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Northern Hospital, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Menzies Institute for Medical Research
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Peter MacCallum Cancer Centre, Australia
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
The Alfred
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tom Marwick, MBBS,PhD,MPH
Address 0 0
Baker Heart and Diabetes Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tom Marwick, MBBS,PhD,MPH
Address 0 0
Country 0 0
Phone 0 0
+61 3 8532 1550
Fax 0 0
Email 0 0
tom.marwick@baker.edu.au
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05366153