Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography
NCT ID: NCT02571803
Last Updated: 2015-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2015-10-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dietary And Lifestyle Counseling
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.
Dietary 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
Optimal Medical Treatment as per 2013 ESC Guidelines on the Management of Stable Coronary Artery Disease.
Optimal Medical Treatment
Patients receiving optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease.
Optimal Medical Treatment
Optimal Medical Treatment as per 2013 ESC Guidelines on the Management of Stable Coronary Artery Disease.
Interventions
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Dietary 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
Optimal Medical Treatment as per 2013 ESC Guidelines on the Management of Stable Coronary Artery Disease.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute of Cardiology, Warsaw, Poland
OTHER
Responsible Party
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Cezary Kepka
Ass. Prof.
Principal Investigators
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Jan Henzel, MD
Role: STUDY_DIRECTOR
National Institute of Cardiology, Warsaw, Poland
Locations
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Institute of Cardiology
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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2.15/III/15
Identifier Type: -
Identifier Source: org_study_id
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