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

Coronary Artery Disease Clinical Trial

— DISCO-CT2  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06031974
• Other study ID #: 2.25/III/23
• Status: Enrolling by invitation
• Start date: January 13, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2023
• Source: National Institute of Cardiology, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 92
• Est. completion date: March 31, 2024
• Est. primary completion date: January 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Diet, Healthy
• Lifestyle Risk Reduction
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Poland	National Institute of Cardiology	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in body mass	in kilograms	60 months
Other	Change in total body fat	expressed in kilograms	60 months
Other	Change in skeletal muscle mass	expressed in kilograms	60 months
Other	Change in fat to muscle ratio	expressed as the relation of fat mass to muscle mass	60 months
Other	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
Other	Change in Visceral Fat Area	Measured as part of body composition analysis, expressed in cm2	60 months
Other	Change in total cholesterol	mg/dL	60 months
Other	Change in low density lipoprotein	mg/dL	60 months
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of major cardiovascular events	myocardial infarction; cardiovascular death; coronary revascularization	60 months