Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Behavioral: Dietary And Lifestyle Counseling; Other: Optimal Medical Treatment

• Registration Number: NCT02571803
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-13
• Last Update Posted: 2015-11-16
• Primary Completion: 2018-06
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary And Lifestyle Counseling	Optimal Medical Treatment	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.
Optimal Medical Treatment	Optimal Medical Treatment	Patients receiving optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease.
Dietary And Lifestyle Counseling	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.

Primary Outcome Measures

Name	Time	Method
Percent Of Patheroma Volume (PAV)	12 months	Reduction of percent atheroma volume (PAV) measured between baseline and follow-up CT scans.

Secondary Outcome Measures

Name	Time	Method
Pericardial Fat Distribution	12 months	Change in pericardial fat distribution between baseline and follow-up CT scans.

Trial Locations

Locations (1)

Institute of Cardiology; 🇵🇱 Warsaw, Poland