Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Strict Dietary Intervention on Atherosclerotic Lesions in Patients Diagnosed With Coronary Artery Disease, Assessed by Coronary Computed Tomography Angiography (CCTA).

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Behavioral: Dietary And Lifestyle Counseling
* Other: Optimal Medical Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: coronary atheroslerotic lesions confirmed in the screening CCTA with reduction of the artery diameter less than 70% in 2 or more coronary artery segments no indications for coronary angiography / revascularization (no documented significant ischemia of myocardium) free and informed consent of the person concerned willingness to follow the strict directions given by the investigators Exclusion Criteria: any valvular heart disease requiring cardiac surgery (or expected cardiac surgery intervention within 12 moths) diagnosis of dilated / hypertrophic cardiomyopathy diagnosis of DM t. 2 past CABG procedure women in reproductive age known genetic factors with a possible impact on the progres of coronary atherosclerotic lesions (e. i. congenital metabolic disorders, familial hyperlipidemias) low quality of the CCTA data

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary And Lifestyle Counseling<br>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. | Behavioral: Dietary And Lifestyle Counseling<br>* 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.<br>* Other names: DASH diet implementation with lifestyle changes support;Other: Optimal Medical Treatment<br>* Optimal Medical Treatment as per 2013 ESC Guidelines on the Management of Stable Coronary Artery Disease.<br>* Other names: OMT;|
| Active Comparator: Optimal Medical Treatment<br>Patients receiving optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease. | Other: Optimal Medical Treatment<br>* Optimal Medical Treatment as per 2013 ESC Guidelines on the Management of Stable Coronary Artery Disease.<br>* Other names: OMT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pericardial Fat Distribution | Change in pericardial fat distribution between baseline and follow-up CT scans. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, atherosclerosis, DASH diet