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

National Institute of Cardiology, Warsaw, Poland

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Other: Optimal Medical Treatment; Behavioral: Dietary And Lifestyle Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT02571803

2.15/III/15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Dietary And Lifestyle Counseling

Experimental group

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.

Treatment:

Behavioral: Dietary And Lifestyle Counseling

Other: Optimal Medical Treatment

Optimal Medical Treatment

Active Comparator group

Description:

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

Treatment:

Other: Optimal Medical Treatment