Coronary Artery DiseaseVIRDICTNCT06083337
Vascular Inflammation ReDuction and Perivascular Fat Imaging by Computed Tomography
A study testing CaRi-Heart device in people with Coronary Artery Disease and Atheroscleroses, Coronary, run by Hippocration General Hospital at 1 site in Greece.
Trial summary
The goal of this clinical trial is to compare the effect of standard of care management vs. CaRi-Heart based management on vascular inflammation in patients with increased Fat Attenuation Index-Score. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Atheroscleroses, Coronary, Vascular Inflammation
- What is being tested?
- CaRi-Heart device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteGreece
- Study dates
- 22 Jan 2022to 22 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must satisfy the following conditions:
- Male or female, aged 30 to 80 years
- CCTA scan showing mild coronary artery plaques (<50% luminal stenosis) and CaRi-Heart Risk ≥ 5% and/or FAI-Score ≥ 75th percentile in the left anterior coronary or right coronary artery or FAI-Score ≥ 95th percentile in the circumflex coronary within the last 6 months.
- Willing and able (in the Investigators opinion) to comply with all study requirements.
- Able to understand both verbal or written Greek
- No definite clinical indication for a change in treatment based on European Society of Cardiology guidelines or planned revascularization
Who cannot join
- The participant may not enter the study if ANY of the following are known to apply:
- Previous documented history of coronary artery disease requiring treatment. This includes any of the following:
- Acute myocardial infarction ii. Unstable angina iii. Coronary revascularization procedure iv. Clinically significant coronary artery disease diagnosed by invasive or non-invasive testing.
- History of New York Heart Association (NYHA) Class III or IV heart failure within the past 12 months of consent.
- Autoimmune disease requiring immunosuppressive therapy or systemic corticosteroid therapy
- Active chronic treatment with any anti-inflammatory agents (e.g. NSAIDs, systemic corticosteroids)
Show all 16Show fewer
- Active neoplasm requiring surgery, chemotherapy, or radiation within the prior 12 months (subjects with a history of malignancy who have undergone curative resection or otherwise not requiring treatment for at least 12 months prior to screening with no detectable recurrence are allowed)
- Contraindication for statin therapy. Patients with intolerance to colchicine therapy may be included but they will receive statin treatment only.
- Severe Chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73 m² and/or serum creatinine > 2.5 mg/dL or 220 µmol/l).
- Hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] > 3 × the upper limit of normal [ULN] measured on local labs in last 6 months)
- Any clinically significant abnormality identified at the time of screening that, in the opinion of the Investigator, would preclude safe completion of the study.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Participants who have participated in another research study involving a treatment intervention or an investigational product, in the past 12 weeks.
- Patients unable to understand verbal or written English.
- Contraindication to contract dye for CCTA.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
1st Cardiology Department, Hippokration General Hospital of Athens
Athens, Attica, 11527
Alexios S Antonopoulos, MD, PhD, +306947607442, antonopoulosal@yahoo.gr
Spyridon D Simantiris, MD, +306949402966, spyrsim@gmail.com
About this study
The goal of this clinical trial is to compare the effect of standard of care management vs. CaRi-Heart based management on vascular inflammation in patients with increased Fat Attenuation Index-Score. The main questions it aims to answer are:
- Does treatment intensification reduce vascular inflammation detected by perivascular fat imaging to a greater extent than standard of care treatment?
- Do changes in vascular inflammation biomarkers correlate with changes in lipid metrics or inflammatory biomarkers, such as interleukin-6?
Participants will be randomized either to standard of care treatment or intensified treatment with maximum dose of atorvastatin +/- low dose of colchicine. After their inclusion, study participants will be followed-up for 6 months with regular monitoring for adverse events and blood will be drawn at 3 and 6 months. After the 6-month follow-up, participants will undergo CCTA imaging for fat attenuation index measurements. Researchers will compare standard of care and vascular inflammation-based treatment to see if inflammation-based treatment is more potent against vascular inflammation.
Read the detailed description
The VIRDICT study is a randomized, open-label clinical study including participants aged 30-80 years old, who underwent coronary computed tomography angiography (CCTA) and had no obstructive coronary stenoses. CCTA images will be transferred as pseudonymized DICOM data to Caristo Diagnostics Ltd for perivascular fat analysis. Individuals with evidence of coronary inflammation, as assessed by fat attenuation index (FAI) will be eligible for the VIRDICT study. Participants will be randomized either to standard of care treatment or inflammation-based treatment with atorvastatin ± colchicine. Participants will be followed-up for 6 months post randomization, with four follow-up visits (two by telephone call and two by onsite visit). At the end of their follow-up, participants will undergo a second CCTA and the relevant images will be analyzed for pericoronary inflammation. 140 participants are expected be included in the study. Interim analyses will be performed after sufficient patients (approximately 80 patients) have completed 24 weeks of follow-up. This is a pilot study to establish the ability of CCTA-derived FAI quantification to detect a change in coronary artery inflammation, following a period of treatment with medications with known anti-inflammatory properties (statin and colchicine).
- Being tested
- CaRi-Heart device
- Keywords
- vascular inflammation, fat attenuation index, pericoronary adipose tissue, coronary computed tomography angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaRi-Heart deviceDevice
Open-label treatment with atorvastatin +/- low-dose colchicine medications based on CaRi-Heart algorithm management.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care management | No intervention | Patients will receive standard of care treatment. |
| Coronary inflammation-based management | Experimental | Participants classified as moderate risk (FAI-Score 75th-89th percentile for the RCA or the LAD or ≥ 95th percentile for the LCx) or CaRi-Heart risk≥ 5% and <10%) will receive atorvastatin 40mg daily, if they do not already receive statin therapy, while if they already receive statin, it will be discontinued and they will be given atorvastatin 80 mg daily. Participants classified as high risk (FAI-Score≥ 90th percentile for the RCA or the LAD or CaRi-Heart risk≥ 10%) will receive atorvastatin 80 mg daily and colchicine 0.5 mg daily. Tolerance and compliance will be monitored during the study follow-up and participants will be informed at enrollment about possible treatment side effects. In case of colchicine intolerance, colchicine will be discontinued. If the patient cannot tolerate atorvastatin, then half dose may be prescribed daily. In case of severe adverse events related to atorvastatin, atorvastatin will be discontinued and the participant will withdraw from the study. Receives: Device: CaRi-Heart device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fat Attenuation Index (FAI) in the proximal right coronary (RCA), left anterior descending (LAD) and circumflex (Cx) coronary arteries
FAI change will be compared between the standard of care arm and the inflammation-based treatment arm
Measured: 6 months
Secondary outcomes (9)
% change in plasma LDL-c
Change in LDL-c will be compared between the standard of care arm and the inflammation-based treatment arm
Measured: 6 months
% change in plasma HDL-c
Change in HDL-c will be compared between the standard of care arm and the inflammation-based treatment arm
Measured: 6 months
% change in plasma triglycerides
Change in triglycerides will be compared between the standard of care arm and the inflammation-based treatment arm
Measured: 6 months
% change in plasma high sensitivity C-reactive protein (hsCRP)
Change in hsCRP values will be compared between the standard of care arm and the inflammation-based treatment arm
Measured: 6 months
% change in plasma IL-6
Change in IL-6 values will be compared between the standard of care arm and the inflammation-based treatment arm
Measured: 6 months
% change and absolute change in FAI-Score
Change in FAI-Score value will be compared between the standard of care arm and the inflammation-based treatment arm
Measured: 6 months
% change and absolute change in CaRi-Heart Risk
Change in CaRi-Heart Risk value will be compared between the standard of care arm and the inflammation-based treatment arm
Measured: 6 months
% change of FAI around identified individual coronary plaques
Change in FAI around identified individual coronary plaques will be compared between the standard of care arm and the inflammation-based treatment arm
Measured: 6 months
FAI around identified individual coronary plaques
FAI around identified individual coronary plaques will be measured in both arms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start22 Jan 2022
- Primary completion22 Jul 2025 (estimated)
- Study completion22 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants of the VIRDICT study will be randomized either to standard of care management or high-dose atorvastatin +/- colchicine.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hippocration General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Biomedical Research Foundation, Academy of Athens
- Responsible party
- Principal investigator, Alexios S. Antonopoulos, Hippocration General Hospital
- Investigators
- Alexios S Antonopoulos, MD, PhD, Principal investigator, 1st Cardiology Department, Hippokration General Hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083337
- Sponsor's protocol ID
- 7121/29-11-2018/00468
- Acronym
- VIRDICT
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Inflammation ReDuction and Perivascular Fat Imaging by Computed Tomography
- ClinicalTrials.gov ID
- NCT06083337
- Acronym / sponsor ID
- VIRDICT / 7121/29-11-2018/00468
- Keywords
- vascular inflammation, fat attenuation index, pericoronary adipose tissue, coronary computed tomography angiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hippocration General HospitalUniversity, hospital or other
- Collaborators
- Biomedical Research Foundation, Academy of Athens
- Study start
- 22 Jan 2022 (actual)
- Primary completion
- 22 Jul 2025 (estimated)
- Study completion
- 22 Jul 2025 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the effect of standard of care management vs. CaRi-Heart based management on vascular inflammation in patients with increased Fat Attenuation Index-Score. The main questions it aims to answer are:
- Does treatment intensification reduce vascular inflammation detected by perivascular fat imaging to a greater extent than standard of care treatment?
- Do changes in vascular inflammation biomarkers correlate with changes in lipid metrics or inflammatory biomarkers, such as interleukin-6?
Participants will be randomized either to standard of care treatment or intensified treatment with maximum dose of atorvastatin +/- low dose of colchicine. After their inclusion, study participants will be followed-up for 6 months with regular monitoring for adverse events and blood will be drawn at 3 and 6 months. After the 6-month follow-up, participants will undergo CCTA imaging for fat attenuation index measurements. Researchers will compare standard of care and vascular inflammation-based treatment to see if inflammation-based treatment is more potent against vascular inflammation.
Detailed description
The VIRDICT study is a randomized, open-label clinical study including participants aged 30-80 years old, who underwent coronary computed tomography angiography (CCTA) and had no obstructive coronary stenoses. CCTA images will be transferred as pseudonymized DICOM data to Caristo Diagnostics Ltd for perivascular fat analysis. Individuals with evidence of coronary inflammation, as assessed by fat attenuation index (FAI) will be eligible for the VIRDICT study. Participants will be randomized either to standard of care treatment or inflammation-based treatment with atorvastatin ± colchicine. Participants will be followed-up for 6 months post randomization, with four follow-up visits (two by telephone call and two by onsite visit). At the end of their follow-up, participants will undergo a second CCTA and the relevant images will be analyzed for pericoronary inflammation. 140 participants are expected be included in the study. Interim analyses will be performed after sufficient patients (approximately 80 patients) have completed 24 weeks of follow-up. This is a pilot study to establish the ability of CCTA-derived FAI quantification to detect a change in coronary artery inflammation, following a period of treatment with medications with known anti-inflammatory properties (statin and colchicine).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants of the VIRDICT study will be randomized either to standard of care management or high-dose atorvastatin +/- colchicine.
| Arm | Type | Receives |
|---|---|---|
| Standard of care management | No intervention | –Patients will receive standard of care treatment. |
| Coronary inflammation-based management | Experimental | Device: CaRi-Heart deviceParticipants classified as moderate risk (FAI-Score 75th-89th percentile for the RCA or the LAD or ≥ 95th percentile for the LCx) or CaRi-Heart risk≥ 5% and <10%) will receive atorvastatin 40mg daily, if they do not already receive statin therapy, while if they already receive statin, it will be discontinued and they will be given atorvastatin 80 mg daily. Participants classified as high risk (FAI-Score≥ 90th percentile for the RCA or the LAD or CaRi-Heart risk≥ 10%) will receive atorvastatin 80 mg daily and colchicine 0.5 mg daily. Tolerance and compliance will be monitored during the study follow-up and participants will be informed at enrollment about possible treatment side effects. In case of colchicine intolerance, colchicine will be discontinued. If the patient cannot tolerate atorvastatin, then half dose may be prescribed daily. In case of severe adverse events related to atorvastatin, atorvastatin will be discontinued and the participant will withdraw from the study. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, aged 30 to 80 years
- CCTA scan showing mild coronary artery plaques (<50% luminal stenosis) and CaRi-Heart Risk ≥ 5% and/or FAI-Score ≥ 75th percentile in the left anterior coronary or right coronary artery or FAI-Score ≥ 95th percentile in the circumflex coronary within the last 6 months.
- Willing and able (in the Investigators opinion) to comply with all study requirements.
- Able to understand both verbal or written Greek
- No definite clinical indication for a change in treatment based on European Society of Cardiology guidelines or planned revascularization
Key exclusion criteria (16 listed)
- Previous documented history of coronary artery disease requiring treatment. This includes any of the following:
- History of New York Heart Association (NYHA) Class III or IV heart failure within the past 12 months of consent.
- Autoimmune disease requiring immunosuppressive therapy or systemic corticosteroid therapy
- Active chronic treatment with any anti-inflammatory agents (e.g. NSAIDs, systemic corticosteroids)
- Active neoplasm requiring surgery, chemotherapy, or radiation within the prior 12 months (subjects with a history of malignancy who have undergone curative resection or otherwise not requiring treatment for at least 12 months prior to screening with no detectable recurrence are allowed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaRi-Heart deviceOpen-label treatment with atorvastatin +/- low-dose colchicine medications based on CaRi-Heart algorithm management. | Device | Coronary inflammation-based management |
Primary outcome
Change in Fat Attenuation Index (FAI) in the proximal right coronary (RCA), left anterior descending (LAD) and circumflex (Cx) coronary arteries
Time frame: 6 months
FAI change will be compared between the standard of care arm and the inflammation-based treatment arm
9 secondary outcomes
% change in plasma LDL-c
Time frame: 6 months
% change in plasma HDL-c
Time frame: 6 months
% change in plasma triglycerides
Time frame: 6 months
% change in plasma high sensitivity C-reactive protein (hsCRP)
Time frame: 6 months
% change in plasma IL-6
Time frame: 6 months
% change and absolute change in FAI-Score
Time frame: 6 months
% change and absolute change in CaRi-Heart Risk
Time frame: 6 months
% change of FAI around identified individual coronary plaques
Time frame: 6 months
FAI around identified individual coronary plaques
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexios S Antonopoulos, MD, PhD principal investigator
1st Cardiology Department, Hippokration General Hospital of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CaRi-Heart device in people with Coronary Artery Disease and Atheroscleroses, Coronary, run by Hippocration General Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexios S Antonopoulos, MD, PhD (+306947607442, antonopoulosal@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fat Attenuation Index (FAI) in the proximal right coronary (RCA), left anterior descending (LAD) and circumflex (Cx) coronary arteries (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.