Clinical trial NCT06031974: Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography: Long-Term Follow-Up
Official title: Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography: Long-Term Follow-Up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Diet, Healthy
Lifestyle Risk Reduction
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Atheroma Volume (Change)
timeFrame: 60 months
measure: Percent Atheroma Volume (PAV) (Change)
timeFrame: 60 months
Secondary outcomes:
measure: Calcified Plaque Volume (Change)
timeFrame: 60 months
measure: Fibrous Plaque Volume (Change)
timeFrame: 60 months
measure: Fibrofatty Plaque Volume (Change)
timeFrame: 60 months
measure: Necrotic Core (Low Density) Plaque Volume (Change)
timeFrame: 60 months
measure: Non-Calcified Plaque Volume (Change)
timeFrame: 60 months
measure: Rate of major cardiovascular events
timeFrame: 60 months
Other outcomes:
measure: Change in body mass
timeFrame: 60 months
measure: Change in total body fat
timeFrame: 60 months
measure: Change in skeletal muscle mass
timeFrame: 60 months
measure: Change in fat to muscle ratio
timeFrame: 60 months
measure: Change in epicardial fat volume
timeFrame: 60 months
measure: Change in Visceral Fat Area
timeFrame: 60 months
measure: Change in total cholesterol
timeFrame: 60 months
measure: Change in low density lipoprotein
timeFrame: 60 months
measure: Change in the DASH Index
timeFrame: 60 months
Locations:
city: Warszawa
country: Poland
facility: National Institute of Cardiology
Study officials:
affiliation: National Institute of Cardiology
name: Jan Henzel
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.