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The aim of the study is to determine, wheather strict dietary intervention with the use of the DASH diet atop of optimal medical treatment reduces previously diagnosed coronary atherosclerotic lesions assessed witch coronary computed tomography.
A total of 180 patients with coronary atheroslerotc lesions confirmed in coronary computed tomography (CCT) will be analyzed in a 12-month observation time. Patients will be randomized to two groups in a 1:1 fashion. 1 - optimal medical treatment, 2 - strict dietary intervention with implementation of the DASH diet atop of optimal medical treatment. CCT scans will be performed at screening and at 12 months after randomization. Computed tomography imaging data describing atheroslerotic lesions will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary And Lifestyle Counseling | Experimental | Patients receiving strict dietary counseling (implementation of the DASH diet) and lifestyle changes support atop of optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease. |
|
| Optimal Medical Treatment | Active Comparator | Patients receiving optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary And Lifestyle Counseling | Behavioral | The DASH (Dietary Approaches to Stop Hypertension) diet is a dietary pattern of proven effect on arterial blood pressure reduction. It is rich in fruits, vegetables, whole grains, and low-fat dairy foods; includes meat, fish, poultry, nuts, and beans; and is limited in sugar-sweetened foods and beverages, red meat, and added fats. Dietary counseling will be provided during each of 7 control visits within the 12-month time of observation. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Of Patheroma Volume (PAV) | Reduction of percent atheroma volume (PAV) measured between baseline and follow-up CT scans. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pericardial Fat Distribution | Change in pericardial fat distribution between baseline and follow-up CT scans. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Henzel, MD | Contact | +48600599211 | jhenzel@ikard.pl | |
| Cezary Kępka, Asst. Prof. | Contact | +48725993883 | ckepka@ikard.pl |
| Name | Affiliation | Role |
|---|---|---|
| Jan Henzel, MD | National Institute of Cardiology, Warsaw, Poland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Cardiology | Recruiting | Warsaw | 04-628 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33341413 | Derived | 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. | |
| 31558416 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
|
| Optimal Medical Treatment | Other | Optimal Medical Treatment as per 2013 ESC Guidelines on the Management of Stable Coronary Artery Disease. |
|
|
| Makarewicz-Wujec M, Henzel J, Kruk M, Kepka C, Wardziak L, Trochimiuk P, Parzonko A, Demkow M, Kozlowska-Wojciechowska M. DASH diet decreases CXCL4 plasma concentration in patients diagnosed with coronary atherosclerotic lesions. Nutr Metab Cardiovasc Dis. 2020 Jan 3;30(1):56-59. doi: 10.1016/j.numecd.2019.07.013. Epub 2019 Jul 24. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |