Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography
DISCO-CT
The Effect of Strict Dietary Intervention on Atherosclerotic Lesions in Patients Diagnosed With Coronary Artery Disease, Assessed by Coronary Computed Tomography Angiography (CCTA).
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Oct 2015
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 7, 2015
CompletedFirst Posted
Study publicly available on registry
October 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedNovember 16, 2015
November 1, 2015
2.7 years
October 7, 2015
November 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Of Patheroma Volume (PAV)
Reduction of percent atheroma volume (PAV) measured between baseline and follow-up CT scans.
12 months
Secondary Outcomes (1)
Pericardial Fat Distribution
12 months
Study Arms (2)
Dietary And Lifestyle Counseling
EXPERIMENTALPatients 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 COMPARATORPatients receiving optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Cardiology
Warsaw, 04-628, Poland
Related Publications (2)
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.
PMID: 33341413DERIVEDMakarewicz-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.
PMID: 31558416DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jan Henzel, MD
National Institute of Cardiology, Warsaw, Poland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass. Prof.
Study Record Dates
First Submitted
October 7, 2015
First Posted
October 8, 2015
Study Start
October 1, 2015
Primary Completion
June 1, 2018
Study Completion
October 1, 2018
Last Updated
November 16, 2015
Record last verified: 2015-11