Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography: Long-Term Follow-Up

Study Overview
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Brief Summary
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A long-term evaluation of the impact of intensive diet and lifestyle intervention on coronary plaque dynamics in patients with coronary atherosclerosis diagnosed in computed tomography angiography (CCTA). 92 patients who completed the Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography study (DISCO-CT, NCT02571803) will be followed-up.

Detailed Description
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All patients who completed the Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography received dietary and lifestyle recommendations and were referred to outpatient specialist care at their place of residence. As part of this study, patients will be invited for a follow-up visit consisting of a cardiological and dietician consultation and additional tests, including CCTA, to assess the long-term impact of the intervention on the progression of atherosclerotic plaques, including high-risk plaque component. Additionally, the occurrence of cardiovascular events, change in laboratory parameters and change in body weight composition will be analyzed.

Official Title
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Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography: Long-Term Follow-Up

Conditions
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Coronary Artery Disease, Diet, Healthy, Lifestyle Risk Reduction

Intervention / Treatment
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* Behavioral: DISCO Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: completion the DISCO-CT study (NCT02571803) willingness to participate in the long-term follow-up at site Exclusion criteria: contraindications to perform coronary computed tomography angiography (history of severe reaction to iodine contrast media, uncontrolled thyreotoxicosis and/or severe renal impairment with glomerular filtration rate < 30 ml/min) no consent to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DISCO Intervention<br>Patients included to the DISCO-CT study and randomized to the experimental arm, ie. subjected to optimal medical treatment in accordance with European Society of Cardiology recommendations + DASH diet (Dietary Approaches to StopHypertension) and strict monitoring of eating and lifestyle behaviors n=46 | Behavioral: DISCO Intervention<br>* optimal medical management in accordance with European Society of Cardiology recommendations + dietary intervention based on Dietary Approaches to Stop Hypertension (DASH diet) + strict monitoring of eating and lifestyle behaviors<br>|
| Control<br>Patients included to the DISCO-CT study and randomized to the control arm, ie. subjected to optimal medical treatment in accordance with European Society of Cardiology recommendations alone n=46 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Atheroma Volume (Change) | Quantitative assessment of the coronary plaque dynamics will be analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study (expressed in mm3) | 60 months | 
| Percent Atheroma Volume (PAV) (Change) | Quantitative assessment of the coronary plaque dynamics will be analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study (expressed in percent) PAV = [(EEM-LA)/EEM]*100% EEM - external elastic membrane area LA - lumen area | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcified Plaque Volume (Change) | Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; calcified plaque volume (expressed in mm3) will be identified according to plaque density in Hounsfield units, on a per-patient basis | 60 months | 
| Fibrous Plaque Volume (Change) | Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; fibrous plaque volume (expressed in mm3) will be identified according to plaque density in Hounsfield units, on a per-patient basis | 60 months | 
| Fibrofatty Plaque Volume (Change) | Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; fibrofatty plaque volume (expressed in mm3) will be identified according to plaque density in Hounsfield units, on a per-patient basis | 60 months | 
| Necrotic Core (Low Density) Plaque Volume (Change) | Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; necrotic (low density) plaque volume (expressed in mm3) will be identified according to plaque density in Hounsfield units, on a per-patient basis | 60 months | 
| Non-Calcified Plaque Volume (Change) | Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; A combined component of fibrofatty + necrotic (low density) plaque (expressed in mm3), measured on a per-patient basis | 60 months | 
| Rate of major cardiovascular events | myocardial infarction cardiovascular death coronary revascularization | 60 months |