Coronary Artery DiseaseDISCO-CTNCT02571803
Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography
A study testing Dietary And Lifestyle Counseling and Optimal Medical Treatment in people with Coronary Artery Disease, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
The aim of the study is to determine, wheather strict dietary intervention with the use of the DASH diet atop of optimal medical treatment reduces previously diagnosed coronary atherosclerotic lesions assessed witch coronary computed tomography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Dietary And Lifestyle Counseling and Optimal Medical Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2015to Oct 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary atheroslerotic lesions confirmed in the screening CCTA with reduction of the artery diameter less than 70% in 2 or more coronary artery segments
- no indications for coronary angiography / revascularization (no documented significant ischemia of myocardium)
- free and informed consent of the person concerned
- willingness to follow the strict directions given by the investigators
Who cannot join
- any valvular heart disease requiring cardiac surgery (or expected cardiac surgery intervention within 12 moths)
- diagnosis of dilated / hypertrophic cardiomyopathy
- diagnosis of DM t. 2
- past CABG procedure
- women in reproductive age
- known genetic factors with a possible impact on the progres of coronary atherosclerotic lesions (e. i. congenital metabolic disorders, familial hyperlipidemias)
- low quality of the CCTA data
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Institute of Cardiology
Warsaw, 04-628
Jan Henzel, MD, +48223434342, jhenzel@ikard.pl
Cezary Kepka, prof., +48223434342, ckepka@ikard.pl
About this study
Official title: The Effect of Strict Dietary Intervention on Atherosclerotic Lesions in Patients Diagnosed With Coronary Artery Disease, Assessed by Coronary Computed Tomography Angiography (CCTA).
The aim of the study is to determine, wheather strict dietary intervention with the use of the DASH diet atop of optimal medical treatment reduces previously diagnosed coronary atherosclerotic lesions assessed witch coronary computed tomography.
Read the detailed description
A total of 180 patients with coronary atheroslerotc lesions confirmed in coronary computed tomography (CCT) will be analyzed in a 12-month observation time. Patients will be randomized to two groups in a 1:1 fashion. 1 - optimal medical treatment, 2 - strict dietary intervention with implementation of the DASH diet atop of optimal medical treatment. CCT scans will be performed at screening and at 12 months after randomization. Computed tomography imaging data describing atheroslerotic lesions will be assessed.
- Conditions
- Coronary Artery Disease
- Being tested
- Dietary And Lifestyle Counseling, Optimal Medical Treatment
- Keywords
- coronary artery disease, atherosclerosis, DASH diet
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary And Lifestyle CounselingBehavioural
Also called DASH diet implementation with lifestyle changes support
The DASH (Dietary Approaches to Stop Hypertension) diet is a dietary pattern of proven effect on arterial blood pressure reduction. It is rich in fruits, vegetables, whole grains, and low-fat dairy foods; includes meat, fish, poultry, nuts, and beans; and is limited in sugar-sweetened foods and beverages, red meat, and added fats. Dietary counseling will be provided during each of 7 control visits within the 12-month time of observation.
Optimal Medical TreatmentOther
Also called OMT
Optimal Medical Treatment as per 2013 ESC Guidelines on the Management of Stable Coronary Artery Disease.
| Study group | Role | What they receive |
|---|---|---|
| Dietary And Lifestyle Counseling | Experimental | Patients receiving strict dietary counseling (implementation of the DASH diet) and lifestyle changes support atop of optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease. Receives: Behavioral: Dietary And Lifestyle Counseling; Other: Optimal Medical Treatment |
| Optimal Medical Treatment | Active comparator | Patients receiving optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease. Receives: Other: Optimal Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Of Patheroma Volume (PAV)
Reduction of percent atheroma volume (PAV) measured between baseline and follow-up CT scans.
Measured: 12 months
Secondary outcomes (1)
Pericardial Fat Distribution
Change in pericardial fat distribution between baseline and follow-up CT scans.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cezary Kepka, National Institute of Cardiology, Warsaw, Poland
- Investigators
- Jan Henzel, MD, Study director, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571803
- Sponsor's protocol ID
- 2.15/III/15
- Acronym
- DISCO-CT
- Status last verified
- Nov 2015
- First submitted
- 7 Oct 2015
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 33341413Makarewicz-Wujec M, Henzel J, Kruk M, Kepka C, Wardziak L, Trochimiuk P, Parzonko A, Demkow M, Kozlowska-Wojciechowska M. DASH diet decreases CXCL4 plasma concentration in patients diagnosed with coronary atherosclerotic lesions. Nutr Metab Cardiovasc Dis. 2020 Jan 3;30(1):56-59. doi: 10.1016/j.numecd.2019.07.013. Epub 2019 Jul 24.
PubMed 31558416
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Strict Dietary Intervention on Atherosclerotic Lesions in Patients Diagnosed With Coronary Artery Disease, Assessed by Coronary Computed Tomography Angiography (CCTA).
- ClinicalTrials.gov ID
- NCT02571803
- Acronym / sponsor ID
- DISCO-CT / 2.15/III/15
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, atherosclerosis, DASH diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 8 Oct 2015 (estimated)
- 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.
The aim of the study is to determine, wheather strict dietary intervention with the use of the DASH diet atop of optimal medical treatment reduces previously diagnosed coronary atherosclerotic lesions assessed witch coronary computed tomography.
Detailed description
A total of 180 patients with coronary atheroslerotc lesions confirmed in coronary computed tomography (CCT) will be analyzed in a 12-month observation time. Patients will be randomized to two groups in a 1:1 fashion. 1 - optimal medical treatment, 2 - strict dietary intervention with implementation of the DASH diet atop of optimal medical treatment. CCT scans will be performed at screening and at 12 months after randomization. Computed tomography imaging data describing atheroslerotic lesions will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary And Lifestyle Counseling | Experimental | Behavioral: Dietary And Lifestyle Counseling, Other: Optimal Medical TreatmentPatients receiving strict dietary counseling (implementation of the DASH diet) and lifestyle changes support atop of optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease. |
| Optimal Medical Treatment | Active comparator | Other: Optimal Medical TreatmentPatients receiving optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- coronary atheroslerotic lesions confirmed in the screening CCTA with reduction of the artery diameter less than 70% in 2 or more coronary artery segments
- no indications for coronary angiography / revascularization (no documented significant ischemia of myocardium)
- free and informed consent of the person concerned
- willingness to follow the strict directions given by the investigators
Key exclusion criteria (7 listed)
- any valvular heart disease requiring cardiac surgery (or expected cardiac surgery intervention within 12 moths)
- diagnosis of dilated / hypertrophic cardiomyopathy
- diagnosis of DM t. 2
- past CABG procedure
- women in reproductive age
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 |
|---|---|---|
| Dietary And Lifestyle CounselingAlso: DASH diet implementation with lifestyle changes supportThe DASH (Dietary Approaches to Stop Hypertension) diet is a dietary pattern of proven effect on arterial blood pressure reduction. It is rich in fruits, vegetables, whole grains, and low-fat dairy foods; includes meat, fish, poultry, nuts, and beans; and is limited in sugar-sweetened foods and beverages, red meat, and added fats. Dietary counseling will be provided during each of 7 control visits within the 12-month time of observation. | Behavioural | Dietary And Lifestyle Counseling |
| Optimal Medical TreatmentAlso: OMTOptimal Medical Treatment as per 2013 ESC Guidelines on the Management of Stable Coronary Artery Disease. | Other | Dietary And Lifestyle Counseling, Optimal Medical Treatment |
Primary outcome
Percent Of Patheroma Volume (PAV)
Time frame: 12 months
Reduction of percent atheroma volume (PAV) measured between baseline and follow-up CT scans.
1 secondary outcome
Pericardial Fat Distribution
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
- Derived from this study: 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.
- Derived from this study: PubMed 31558416Makarewicz-Wujec M, Henzel J, Kruk M, Kepka C, Wardziak L, Trochimiuk P, Parzonko A, Demkow M, Kozlowska-Wojciechowska M. DASH diet decreases CXCL4 plasma concentration in patients diagnosed with coronary atherosclerotic lesions. Nutr Metab Cardiovasc Dis. 2020 Jan 3;30(1):56-59. doi: 10.1016/j.numecd.2019.07.013. Epub 2019 Jul 24.
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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, MD study director
National Institute of Cardiology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary And Lifestyle Counseling and Optimal Medical Treatment in people with Coronary Artery Disease, 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 4 inclusion and 7 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 16 Nov 2015. 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?
Contact Jan Henzel, MD (+48600599211, jhenzel@ikard.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Of Patheroma Volume (PAV) (time frame: 12 months). 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 NCT02571803, which also lists 2 linked publications.
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 16 Nov 2015.