NCT06031974

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

October 6, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

April 25, 2023

Last Update Submit

October 4, 2023

Conditions

Coronary Artery DiseaseDiet, HealthyLifestyle Risk Reduction

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Calcified Plaque Volume (Change)

    60 months

  • Fibrous Plaque Volume (Change)

    60 months

  • Fibrofatty Plaque Volume (Change)

    60 months

  • Necrotic Core (Low Density) Plaque Volume (Change)

    60 months

  • Non-Calcified Plaque Volume (Change)

    60 months

  • +1 more secondary outcomes

Other Outcomes (9)

  • Change in body mass

    60 months

  • Change in total body fat

    60 months

  • Change in skeletal muscle mass

    60 months

  • +6 more other outcomes

Study Arms (2)

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

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

Interventions

DISCO InterventionBEHAVIORAL

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

DISCO Intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cardiology

Warsaw, 04-628, Poland

Location

Related 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.

    PMID: 33341413BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Coronary Artery DiseaseRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesBehavior

Study Officials

  • Jan Henzel

    National Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2023

First Posted

September 11, 2023

Study Start

January 13, 2023

Primary Completion

January 13, 2024

Study Completion

March 31, 2024

Last Updated

October 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)