- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02571803
Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography (DISCO-CT)
November 13, 2015 updated by: Cezary Kepka, Institute of Cardiology, Warsaw, Poland
The Effect of Strict Dietary Intervention on Atherosclerotic Lesions in Patients Diagnosed With Coronary Artery Disease, Assessed by Coronary Computed Tomography Angiography (CCTA).
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jan Henzel, MD
- Phone Number: +48600599211
- Email: jhenzel@ikard.pl
Study Contact Backup
- Name: Cezary Kępka, Asst. Prof.
- Phone Number: +48725993883
- Email: ckepka@ikard.pl
Study Locations
-
-
-
Warsaw, Poland, 04-628
- Recruiting
- Institute of Cardiology
-
Contact:
- Jan Henzel, MD
- Phone Number: +48223434342
- Email: jhenzel@ikard.pl
-
Contact:
- Cezary Kepka, prof.
- Phone Number: +48223434342
- Email: ckepka@ikard.pl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
Other Names:
Optimal Medical Treatment as per 2013 ESC Guidelines on the Management of Stable Coronary Artery Disease.
Other Names:
|
Active Comparator: Optimal Medical Treatment
Patients receiving optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease.
|
Optimal Medical Treatment as per 2013 ESC Guidelines on the Management of Stable Coronary Artery Disease.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Of Patheroma Volume (PAV)
Time Frame: 12 months
|
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
Time Frame: 12 months
|
Change in pericardial fat distribution between baseline and follow-up CT scans.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jan Henzel, MD, Institute of Cardiology, Warsaw, Poland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Anticipated)
June 1, 2018
Study Completion (Anticipated)
October 1, 2018
Study Registration Dates
First Submitted
October 7, 2015
First Submitted That Met QC Criteria
October 7, 2015
First Posted (Estimate)
October 8, 2015
Study Record Updates
Last Update Posted (Estimate)
November 16, 2015
Last Update Submitted That Met QC Criteria
November 13, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2.15/III/15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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