EValuation Of poLygenic Scores and CT imAging In Risk Factor Modification in Patients With diabEtes

NCT07091162 | Recruiting

• 1 other identifier: VOLTAIRE-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases; Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

• Change in non-calcified plaque volume, with Bonferroni correction at 12 months

  From baseline CT to the end of study at 12 months

Secondary Outcomes (17)

• Number of Participants achieving LDL-C <1.8 mmol/L

  12 months

• Number of Participants who undergo intensification of lipid-lowering therapy

  12 months

• Number of participants reporting high levels of adherence to their prescribed medications

  12 months

• Change in level of patient activation and engagement in their care, measured by PAM-13 questionnaire

  12 months

• Change in depressive symptoms, measured by the Patient Health Questionnaire-9 (PHQ-9)

  12 months

Other Outcomes (6)

• Participant-reported appropriateness of the CTCA intervention

  12 months

• Participant-reported feasibility of the CTCA intervention

  12 months

• Participant-reported acceptability of the CTCA intervention

  12 months

Study Arms (3)

1. CTCA group

ACTIVE COMPARATOR

Participants receive baseline CTCA results, in addition to standard care

Other: CTCA results

2. PRS group

ACTIVE COMPARATOR

Participants receive polygenic risk score result, in addition to standard care

Other: PRS results

3. Control group

NO INTERVENTION

Participants receive standard care only with no additional information

Interventions

CTCA results OTHER

Participants who are assigned to CTCA group will receive their CTCA results

1. CTCA group

PRS results OTHER

Participants who are assigned to PRS group will receive their PRS results

2. PRS group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Unable to participate in the study or complete protocol required assessments in the opinion of the Investigator

Sponsors & Collaborators

• Monash University: lead

Study Sites (1)

Victorian Heart Hospital

Melbourne, Victoria, 3168, Australia

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stephen J Nicholls, MBBS, PhD

  Monash University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Domenic Sacca

CONTACT

0423245187; domenic.sacca@monash.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 29, 2025
• Study Start: July 25, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)