Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography: Long-Term Follow-Up

• Conditions: Diet, Healthy; Lifestyle Risk Reduction; Coronary Artery Disease
• Interventions: Behavioral: DISCO Intervention

• Registration Number: NCT06031974
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

Brief Summary

A long-term evaluation of the impact of intensive diet and lifestyle intervention on coronary plaque dynamics in patients with coronary atherosclerosis diagnosed in computed tomography angiography (CCTA).

92 patients who completed the Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography study (DISCO-CT, NCT02571803) will be followed-up.

Detailed Description

All patients who completed the Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography received dietary and lifestyle recommendations and were referred to outpatient specialist care at their place of residence.

As part of this study, patients will be invited for a follow-up visit consisting of a cardiological and dietician consultation and additional tests, including CCTA, to assess the long-term impact of the intervention on the progression of atherosclerotic plaques, including high-risk plaque component.

Additionally, the occurrence of cardiovascular events, change in laboratory parameters and change in body weight composition will be analyzed.

Study Timeline

• Study Start: 2023-01-13
• Status Verified: 2023-04
• Study First Submitted: 2023-04-25
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-11
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-06
• Primary Completion: 2024-01-13
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DISCO Intervention	DISCO Intervention	Patients included to the DISCO-CT study and randomized to the experimental arm, ie. subjected to optimal medical treatment in accordance with European Society of Cardiology recommendations + DASH diet (Dietary Approaches to StopHypertension) and strict monitoring of eating and lifestyle behaviors n=46

Primary Outcome Measures

Name	Time	Method
Percent Atheroma Volume (PAV) (Change)	60 months	Quantitative assessment of the coronary plaque dynamics will be analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study (expressed in percent); PAV = \[(EEM-LA)/EEM\]\*100%; EEM - external elastic membrane area LA - lumen area
Total Atheroma Volume (Change)	60 months	Quantitative assessment of the coronary plaque dynamics will be analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study (expressed in mm3)

Secondary Outcome Measures

Name	Time	Method
Calcified Plaque Volume (Change)	60 months	Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; calcified plaque volume (expressed in mm3) will be identified according to plaque density in Hounsfield units, on a per-patient basis
Rate of major cardiovascular events	60 months	* myocardial infarction; * cardiovascular death; * coronary revascularization
Fibrous Plaque Volume (Change)	60 months	Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; fibrous plaque volume (expressed in mm3) will be identified according to plaque density in Hounsfield units, on a per-patient basis
Fibrofatty Plaque Volume (Change)	60 months	Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; fibrofatty plaque volume (expressed in mm3) will be identified according to plaque density in Hounsfield units, on a per-patient basis
Necrotic Core (Low Density) Plaque Volume (Change)	60 months	Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; necrotic (low density) plaque volume (expressed in mm3) will be identified according to plaque density in Hounsfield units, on a per-patient basis
Non-Calcified Plaque Volume (Change)	60 months	Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; A combined component of fibrofatty + necrotic (low density) plaque (expressed in mm3), measured on a per-patient basis

Trial Locations

Locations (1)

National Institute of Cardiology; 🇵🇱 Warszawa, Poland