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

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ClinicalTrials.gov Identifier: NCT06031974
Recruitment Status : Enrolling by invitation
First Posted : September 11, 2023
Last Update Posted : October 6, 2023
Sponsor:
Information provided by (Responsible Party):
National Institute of Cardiology, Warsaw, Poland

Study Description
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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.


Condition or disease Intervention/treatment
Coronary Artery Disease Diet, Healthy Lifestyle Risk Reduction 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 Design
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Study Type : Observational
Estimated Enrollment : 92 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography: Long-Term Follow-Up
Actual Study Start Date : January 13, 2023
Estimated Primary Completion Date : January 13, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Total Atheroma Volume (Change) [ Time Frame: 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)

  2. Percent Atheroma Volume (PAV) (Change) [ Time Frame: 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



Secondary Outcome Measures :
  1. Calcified Plaque Volume (Change) [ Time Frame: 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

  2. Fibrous Plaque Volume (Change) [ Time Frame: 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

  3. Fibrofatty Plaque Volume (Change) [ Time Frame: 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

  4. Necrotic Core (Low Density) Plaque Volume (Change) [ Time Frame: 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

  5. Non-Calcified Plaque Volume (Change) [ Time Frame: 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


  6. Rate of major cardiovascular events [ Time Frame: 60 months ]
    • myocardial infarction
    • cardiovascular death
    • coronary revascularization


Other Outcome Measures:
  1. Change in body mass [ Time Frame: 60 months ]
    in kilograms

  2. Change in total body fat [ Time Frame: 60 months ]
    expressed in kilograms

  3. Change in skeletal muscle mass [ Time Frame: 60 months ]
    expressed in kilograms

  4. Change in fat to muscle ratio [ Time Frame: 60 months ]
    expressed as the relation of fat mass to muscle mass

  5. Change in epicardial fat volume [ Time Frame: 60 months ]
    semiautomated measurements based on the density in Hounsfield units performed in computed tomography angiography and expressed in cm3

  6. Change in Visceral Fat Area [ Time Frame: 60 months ]
    Measured as part of body composition analysis, expressed in cm2

  7. Change in total cholesterol [ Time Frame: 60 months ]
    mg/dL

  8. Change in low density lipoprotein [ Time Frame: 60 months ]
    mg/dL

  9. Change in the DASH Index [ Time Frame: 60 months ]
    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)


Biospecimen Retention:   Samples Without DNA
Plasma

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06031974


Locations
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Poland
National Institute of Cardiology
Warszawa, Poland, 04-628
Sponsors and Collaborators
National Institute of Cardiology, Warsaw, Poland
Investigators
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Principal Investigator: Jan Henzel National Institute of Cardiology
More Information
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Publications:

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Responsible Party: National Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT06031974    
Other Study ID Numbers: 2.25/III/23
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: October 6, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Atherosclerosis
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases