EValuation Of poLygenic Scores and CT imAging In Risk Factor Modification in Patients With diabEtes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorMonash University
About this trial
This study is a three-arm, parallel-group, randomised controlled trial evaluating the effect of using cardiac CT imaging or polygenic risk score in cardiovascular risk factor modification in patients with diabetes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 40 years or older
Established diagnosis of T2DM
Having acceptable imaging quality as deemed by the VHI-AICL
Able to have a PRS calculated
Disqualifiers
Unable to provide written informed consent.
Unwilling to be followed for serial evaluation
Clinically manifest CV disease
Evidence of clinically significant coronary disease on CT that would preclude masking from participant's treating clinician for the duration of the study on the grounds of safety, including but not limited to, equal/greater than 50% in the left main coronary artery or equal/greater than 70% in any epicardial coronary artery
Trial design
Design model
Parallel
Treatments tested in this trial
CTCA results
Other interventionParticipants who are assigned to CTCA group will receive their CTCA results
PRS results
Other interventionParticipants who are assigned to PRS group will receive their PRS results
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: 1. CTCA groupActive comparator 1 intervention
Group B: 2. PRS groupActive comparator 1 intervention
Group C: 3. Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in non-calcified plaque volume, with Bonferroni correction at 12 months
Time frame
From baseline CT to the end of study at 12 monthsSecondary outcomes
1
Number of Participants achieving LDL-C <1.8 mmol/L
Time frame
12 months2
Number of Participants who undergo intensification of lipid-lowering therapy
Intensification of lipid-lowering therapy at 12 months will be defined as the occurrence of any of the following: * an increase in the intensity of statin prescribed, * addition of ezetimibe, or * addition of a PCSK9 inhibitor (PCSK9i). This outcome will be assessed based on medication records at the 12-month follow-up.
Time frame
12 months3
Number of participants reporting high levels of adherence to their prescribed medications
Medication adherence will be assessed using a participant-reported item from a modified VOILS questionnaire at the 12-month follow-up. Participants are asked: "In the last week, I took my tablet(s):" with response options: * Every day * Almost every day * Less than half * Rarely or not at all Adherence will be defined as selecting "Every day", and the number of participants meeting this criterion will be reported.
Time frame
12 months4
Change in level of patient activation and engagement in their care, measured by PAM-13 questionnaire
Patient activation and engagement in care will be assessed using the 13-item Patient Activation Measure (PAM-13) at baseline and 12 months. Each item is scored on a 4-point Likert scale (Disagree Strongly to Agree Strongly), with responses converted into a continuous score ranging from 0 to 100. Higher scores indicate greater activation, reflecting better self-management and engagement in health care.
Time frame
12 monthsOther outcomes
1
Participant-reported appropriateness of the CTCA intervention
Appropriateness will be assessed using a custom participant survey and focus group interviews. Participants will rate whether they found the CTCA intervention relevant and suitable for their personal health needs. Responses will be summarised using Likert scales and thematic analysis.
Time frame
12 months2
Participant-reported feasibility of the CTCA intervention
Feasibility will be assessed through participant survey items and focus group discussions addressing clarity of instructions. Responses will be summarised using Likert scales and thematic analysis.
Time frame
12 months3
Participant-reported acceptability of the CTCA intervention
Acceptability will be measured using participant survey and focus group feedback on comfort, satisfaction, and willingness to undergo CTCA again. Ratings will be reported using Likert scales and thematic analysis.
Time frame
12 months4
Participant-reported appropriateness of the PRS intervention
Appropriateness will be assessed using a custom participant survey and focus group interviews. Participants will rate whether they found the PRS intervention relevant and suitable for their personal health needs. Responses will be summarised using Likert scales and thematic analysis.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov