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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DISCO Intervention | 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 |
| |
| Control | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DISCO Intervention | Behavioral | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass | in kilograms | 60 months |
| Change in total body fat | expressed in kilograms | 60 months |
Inclusion criteria:
Exclusion criteria:
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The study population will be a group of participants of the DISCO-CT study (NCT02571803) who will be willing to participate in the long-term follow-up at site.
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| Name | Affiliation | Role |
|---|---|---|
| Jan Henzel | National Institute of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Cardiology | Warsaw | 04-628 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33341413 | Background | Henzel J, Kepka C, Kruk M, Makarewicz-Wujec M, Wardziak L, Trochimiuk P, Dzielinska Z, Demkow M. High-Risk Coronary Plaque Regression After Intensive Lifestyle Intervention in Nonobstructive Coronary Disease: A Randomized Study. JACC Cardiovasc Imaging. 2021 Jun;14(6):1192-1202. doi: 10.1016/j.jcmg.2020.10.019. Epub 2020 Dec 16. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Plasma
| 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 |
| 60 months |
| Change in skeletal muscle mass | expressed in kilograms | 60 months |
| Change in fat to muscle ratio | expressed as the relation of fat mass to muscle mass | 60 months |
| Change in epicardial fat volume | semiautomated measurements based on the density in Hounsfield units performed in computed tomography angiography and expressed in cm3 | 60 months |
| Change in Visceral Fat Area | Measured as part of body composition analysis, expressed in cm2 | 60 months |
| Change in total cholesterol | mg/dL | 60 months |
| Change in low density lipoprotein | mg/dL | 60 months |
| Change in the DASH Index | adherence to the DASH plan in 8 main groups of foodstuffs (cereal products, vegetables, fruits, dairy products, meat, nuts/seeds, fats/oils, and sweets), with a maximum score of 10 per group (total 0 to 80) | 60 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001519 | Behavior |