DISCO-CT2: Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography: Long-Term Follow-Up
Study Details
Study Description
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 COronart Atherosclerosis in Computed Tomography study (DISCO-CT, NCT02571803) will be followed-up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
All patients who completed the Dietary Intervention to Stop COronart 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 Design
Arms and Interventions
| Arm | 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 |
Outcome Measures
Primary Outcome Measures
- 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)
- Percent 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 percent) PAV = [(EEM-LA)/EEM]*100% EEM - extrernal elastic membrane area LA - lumen area
Secondary Outcome Measures
- 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 indentified according to plaque density in Hounsfield units, on a per-patient basis
- 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 indentified 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 indentified 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) palque volume (expressed in mm3) will be indentified 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
- Rate of major cardiovascular events [60 months]
myocardial infarction cardiovascular death coronary revascularization
Other Outcome Measures
- Change in body mass [60 months]
in kilograms
- Change in total body fat [60 months]
expressed in kilograms
- Change in skeletal muscle mass [60 months]
expressed in kilograms
- Change in fat to muscle ratio [60 months]
expressed as the relation of fat mass to muscle mass
- Change in epicardial fat volume [60 months]
semiautomated measurements based on the density in Hounsfield units performed in computed tomography angiography and expressed in cm3
- Change in Visceral Fat Area [60 months]
Measured as part of body composition analysis, expressed in cm2
- Change in total cholesterol [60 months]
mg/dL
- Change in low density lipoprotein [60 months]
mg/dL
- Change in the DASH Index [60 months]
adherence to the DASH plan in 8 main groups of foodstuffs (cerealproducts, vegetables, fruits, dairy products, meat,nuts/seeds, fats/oils, and sweets), with a maximumscore of 10 per group (total 0 to 80)
Eligibility Criteria
Criteria
Inclusion criteria:
-
completion the DISCO-CT study (NCT02571803)
-
willingness to participate in the long-term follow-up at site
Exlusion criteria:
-
contraindications to perform coronary computed tomography angiography (history of severe reaction to iodine contrast media, uncontrolled thyreotoxicosis and/or severe renal impairment with GFR < 30 ml/min)
-
no consent to participate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institute of Cardiology | Warszawa | Poland | 04-628 |
Sponsors and Collaborators
- National Institute of Cardiology, Warsaw, Poland
Investigators
- Principal Investigator: Jan Henzel, National Institute of Cardiology
Study Documents (Full-Text)
None provided.More Information
Publications
- 2.25/III/23