Coronary Artery Disease
Conditions
Keywords
coronary artery disease, atherosclerosis, DASH diet
Brief summary
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
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.
Interventions
BEHAVIORALDietary And Lifestyle Counseling
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.
Optimal Medical Treatment as per 2013 ESC Guidelines on the Management of Stable Coronary Artery Disease.
Sponsors
National Institute of Cardiology, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Of Patheroma Volume (PAV) | 12 months | Reduction of percent atheroma volume (PAV) measured between baseline and follow-up CT scans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pericardial Fat Distribution | 12 months | Change in pericardial fat distribution between baseline and follow-up CT scans. |
Countries
Poland
Contacts
Primary ContactJan Henzel, MD
Backup ContactCezary Kępka, Asst. Prof.
Outcome results
None listed