Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography

Coronary Artery Disease Clinical Trial

— 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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02571803
• Other study ID #: 2.15/III/15
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2015
• Last updated: November 13, 2015
• Start date: October 2015
• Est. completion date: October 2018

Study information

• Verified date: November 2015
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: Jan Henzel, MD
• Phone: +48600599211
• Email: jhenzel[@]ikard.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: October 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• 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.

Other:
• Optimal Medical Treatment
Optimal Medical Treatment as per 2013 ESC Guidelines on the Management of Stable Coronary Artery Disease.

Locations

Country	Name	City	State
Poland	Institute of Cardiology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Of Patheroma Volume (PAV)	Reduction of percent atheroma volume (PAV) measured between baseline and follow-up CT scans.	12 months	No
Secondary	Pericardial Fat Distribution	Change in pericardial fat distribution between baseline and follow-up CT scans.	12 months	No