Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography: Long-Term Follow-Up (DISCO-CT2)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Coronary Artery Disease; Diet, Healthy; Lifestyle Risk Reduction
• Intervention / Treatment: Behavioral: DISCO Intervention

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 Type: Observational
• Enrollment (Estimated): 92

Contacts and Locations

Study Locations

• Poland
  • Warszawa, Poland, 04-628
    • National Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will be a group of participants of the DISCO-CT study (NCT02571803) who will be willing to participate in the long-term follow-up at site.

Description

Inclusion criteria:

• completion the DISCO-CT study (NCT02571803)
• willingness to participate in the long-term follow-up at site

Exclusion criteria:

• contraindications to perform coronary computed tomography angiography (history of severe reaction to iodine contrast media, uncontrolled thyreotoxicosis and/or severe renal impairment with glomerular filtration rate < 30 ml/min)
• no consent to participate

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Behavioral: DISCO Intervention; optimal medical management in accordance with European Society of Cardiology recommendations + dietary intervention based on Dietary Approaches to Stop Hypertension (DASH diet) + strict monitoring of eating and lifestyle behaviors
Control; Patients included to the DISCO-CT study and randomized to the control arm, ie. subjected to optimal medical treatment in accordance with European Society of Cardiology recommendations alone n=46

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Atheroma Volume (Change)	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)	60 months
Percent Atheroma Volume (PAV) (Change)	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	60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-Calcified Plaque Volume (Change)	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	60 months
Rate of major cardiovascular events	myocardial infarction; cardiovascular death; coronary revascularization	60 months
Calcified Plaque Volume (Change)	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	60 months
Fibrous Plaque Volume (Change)	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	60 months
Fibrofatty Plaque Volume (Change)	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	60 months
Necrotic Core (Low Density) Plaque Volume (Change)	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	60 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body mass	in kilograms	60 months
Change in total body fat	expressed in kilograms	60 months
Change in skeletal muscle mass	expressed in kilograms	60 months
Change in fat to muscle ratio	expressed as the relation of fat mass to muscle mass	60 months
Change in epicardial fat volume	semiautomated measurements based on the density in Hounsfield units performed in computed tomography angiography and expressed in cm3	60 months
Change in Visceral Fat Area	Measured as part of body composition analysis, expressed in cm2	60 months
Change in total cholesterol	mg/dL	60 months
Change in low density lipoprotein	mg/dL	60 months
Change in the DASH Index	adherence to the DASH plan in 8 main groups of foodstuffs (cereal products, vegetables, fruits, dairy products, meat, nuts/seeds, fats/oils, and sweets), with a maximum score of 10 per group (total 0 to 80)	60 months

Collaborators and Investigators

• Sponsor: National Institute of Cardiology, Warsaw, Poland
• Investigators: Principal Investigator: Jan Henzel, National Institute of Cardiology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2023
• Primary Completion (Estimated): January 13, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis
• Other Study ID Numbers: 2.25/III/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No