Coronary Artery DiseaseDISCO-CT2NCT06031974
Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography: Long-Term Follow-Up
An observational study of Coronary Artery Disease and Diet, Healthy, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Diet, Healthy, Lifestyle Risk Reduction
- What is being tested?
- DISCO Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 92 participants
- Where
- 1 sitePoland
- Study dates
- 13 Jan 2023to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- completion the DISCO-CT study (NCT02571803)
- willingness to participate in the long-term follow-up at site
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- DISCO Intervention
- Medical subject headings
- Coronary Artery Disease, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DISCO InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 60 months
Secondary outcomes (6)
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
Measured: 60 months
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
Measured: 60 months
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
Measured: 60 months
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
Measured: 60 months
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
Measured: 60 months
Rate of major cardiovascular events
- myocardial infarction
- cardiovascular death
- coronary revascularization
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start13 Jan 2023
- Primary completion13 Jan 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Henzel, Principal investigator, National Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031974
- Sponsor's protocol ID
- 2.25/III/23
- Acronym
- DISCO-CT2
- Status last verified
- Apr 2023
- First submitted
- 25 Apr 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33341413
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography: Long-Term Follow-Up
- ClinicalTrials.gov ID
- NCT06031974
- Acronym / sponsor ID
- DISCO-CT2 / 2.25/III/23
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 13 Jan 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DISCO Intervention | – | Behavioral: DISCO InterventionPatients 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 |
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- completion the DISCO-CT study (NCT02571803)
- willingness to participate in the long-term follow-up at site
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DISCO Interventionoptimal 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 | Behavioural | DISCO Intervention |
Primary outcome
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)
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
6 secondary outcomes
Calcified Plaque Volume (Change)
Time frame: 60 months
Fibrous Plaque Volume (Change)
Time frame: 60 months
Fibrofatty Plaque Volume (Change)
Time frame: 60 months
Necrotic Core (Low Density) Plaque Volume (Change)
Time frame: 60 months
Non-Calcified Plaque Volume (Change)
Time frame: 60 months
Rate of major cardiovascular events
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 33341413Henzel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Henzel principal investigator
National Institute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Diet, Healthy, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Atheroma Volume (Change) (time frame: 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06031974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.