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Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography (DISCO-CT)

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Dietary And Lifestyle Counseling
Optimal Medical Treatment
Sponsored by
National Institute of Cardiology, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, atherosclerosis, DASH diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dietary And Lifestyle Counseling

Optimal Medical Treatment

Arm Description

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.

Patients receiving optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease.

Outcomes

Primary Outcome Measures

Percent Of Patheroma Volume (PAV)
Reduction of percent atheroma volume (PAV) measured between baseline and follow-up CT scans.

Secondary Outcome Measures

Pericardial Fat Distribution
Change in pericardial fat distribution between baseline and follow-up CT scans.

Full Information

First Posted
October 7, 2015
Last Updated
November 13, 2015
Sponsor
National Institute of Cardiology, Warsaw, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT02571803
Brief Title
Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography
Acronym
DISCO-CT
Official Title
The Effect of Strict Dietary Intervention on Atherosclerotic Lesions in Patients Diagnosed With Coronary Artery Disease, Assessed by Coronary Computed Tomography Angiography (CCTA).
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Cardiology, Warsaw, Poland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, atherosclerosis, DASH diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dietary And Lifestyle Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Optimal Medical Treatment
Arm Type
Active Comparator
Arm Description
Patients receiving optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease.
Intervention Type
Behavioral
Intervention Name(s)
Dietary And Lifestyle Counseling
Other Intervention Name(s)
DASH diet implementation with lifestyle changes support
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Optimal Medical Treatment
Other Intervention Name(s)
OMT
Intervention Description
Optimal Medical Treatment as per 2013 ESC Guidelines on the Management of Stable Coronary Artery Disease.
Primary Outcome Measure Information:
Title
Percent Of Patheroma Volume (PAV)
Description
Reduction of percent atheroma volume (PAV) measured between baseline and follow-up CT scans.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pericardial Fat Distribution
Description
Change in pericardial fat distribution between baseline and follow-up CT scans.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Henzel, MD
Phone
+48600599211
Email
jhenzel@ikard.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Cezary Kępka, Asst. Prof.
Phone
+48725993883
Email
ckepka@ikard.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Henzel, MD
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Cardiology
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Henzel, MD
Phone
+48223434342
Email
jhenzel@ikard.pl
First Name & Middle Initial & Last Name & Degree
Cezary Kepka, prof.
Phone
+48223434342
Email
ckepka@ikard.pl

12. IPD Sharing Statement

Citations:
PubMed Identifier
33341413
Citation
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.
Results Reference
derived
PubMed Identifier
31558416
Citation
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.
Results Reference
derived

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Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography

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