Myocardial Infarction FirstPBN in IMNCT07576400
Dietary Interventions in the Secondary Prevention of Myocardial Infarction: Focus on Plant-Based Nutrition
A study testing Plant based diet and Diet based on the recommendations of the European Society of Cardiology in people with Myocardial Infarction First, run by Radana Dymáčková at 1 site in Czechia.
Trial summary
The goal of this clinical trial is to evaluate whether short-term dietary interventions can improve cardiometabolic risk factors in patients after myocardial infarction. The study includes adult patients following myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myocardial Infarction First
- What is being tested?
- Plant based diet and Diet based on the recommendations of the European Society of Cardiology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Jan 2022to 1 Dec 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Myocardial Infarction First
Who cannot join
- Myocardial Infarction Second
- Age under 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Diet in the Secondary Prevention of Myocardial Infarction, With a Focus on a Plant-Based Diet
The goal of this clinical trial is to evaluate whether short-term dietary interventions can improve cardiometabolic risk factors in patients after myocardial infarction. The study includes adult patients following myocardial infarction.
The main questions it aims to answer are:
Read more
- Does adherence to an ESC-recommended diet lead to improvements in lipid profile and body composition compared with no dietary intervention?
- Does a plant-based (vegan) diet lead to similar or greater improvements in cardiometabolic parameters compared with the control group? Researchers will compare the ESC diet group and the plant-based diet group with a control group to assess their effects on body mass index, lipid profile, and inflammatory markers.
Participants will:
- be assigned to one of three groups (ESC diet, plant-based diet, or control),
- receive dietary counselling according to their assigned group (intervention groups),
- follow the assigned dietary pattern for 3 months,
- undergo baseline and follow-up clinical and laboratory assessments, including anthropometric measurements and blood sampling.
Read the detailed description
This was a single-center, three-arm, controlled, partially randomized interventional pilot study designed to evaluate the feasibility and potential effects of dietary modification in the secondary prevention of myocardial infarction over a three-month period. Participants were recruited between January 2022 and December 2025. The study duration was three months.
Participants who agreed to change their dietary habits were randomized in a 1:1 ratio into two intervention groups using stratified block randomization according to diabetes mellitus status and smoking status. Group A followed a diet based on the recommendations of the European Society of Cardiology (ESC), while Group B adopted a strictly plant-based (vegan) diet.
Patients who declined dietary modification but agreed to undergo study assessments were included as a parallel, non-intervention control group (Group C), based on patient preference.
All participants underwent clinical and laboratory assessments at baseline and at three months, including body composition analysis using bioimpedance (InBody). In the intervention groups, additional scheduled visits were conducted at monthly intervals during the three-month period. At these visits, participants received nutritional counseling from a registered dietitian and completed a three-day dietary record to assess dietary intake and adherence. Participants were additionally allowed to contact the dietitian or the study physician outside the scheduled visits if needed.
Laboratory analyses included lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, lipoprotein(a), triglycerides), glycemic parameters (fasting blood glucose, glycated hemoglobin HbA1c), inflammatory markers (high-sensitivity C-reactive protein (hsCRP) and interleukin-6 (IL-6)), vitamin B12, vitamin D, iron metabolism, complete blood count, and basic biochemical parameters.
Patient recruitment was conducted in collaboration with the coronary care unit of St. Anne's University Hospital Brno (FNUSA). Nutritional counselling was delivered by trained Master's degree nutrition therapy students from the Faculty of Medicine, Masaryk University.
- Conditions
- Myocardial Infarction First
- Being tested
- Plant based diet, Diet based on the recommendations of the European Society of Cardiology
- Keywords
- Myocardial Infarction, Plant based diet, Diet recommended European Society of Cardiology
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant based dietOther
Change dietary habits for tree months
Diet based on the recommendations of the European Society of CardiologyOther
Change dietary habits for tree months
| Study group | Role | What they receive |
|---|---|---|
| Plant based diet | Experimental | The intervention arm, in which participants switch to a strictly plant-based (vegan) diet for three months. Receives: Other: Plant based diet |
| Diet based on the recommendations of the European Society of Cardiology | Experimental | The intervention arm, in which participants switch to a diet based on the recommendations of the European Society of Cardiology for three months. Receives: Other: Diet based on the recommendations of the European Society of Cardiology |
| Control arm | No intervention | Patients who declined dietary modification but agreed to undergo study assessments were included as a parallel, non-intervention control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants enrolled in the study
In percentage terms, the number of patients contacted and the proportion of those who were subsequently enrolled.
Measured: 48 months
Percentage of participants completed the study
Percentage of the enrolled patients completed the study.
Measured: 3 month
Secondary outcomes (25)
Changes in weight after diet changes
Change from baseline InBody - bioelectrical impedance analysis Unit: kg
Measured: 3 months
Changes in viceral fat area after diet changes
Change from baseline. InBody - bioelectrical impedance analysis Unit: cm3
Measured: 3 month
Changes in skeletal muscle mass after diet changes
Change from baseline InBody - bioelectrical impedance analysis Unit: kg
Measured: 3 month
Changes in body fat mass after diet changes
Change in baseline InBody - bioelectrical impedance analysis Unit: kg
Measured: 3 month
Changes in total body water after diet changes
Change from baseline InBody - bioelectrical impedance analysis Unit: litr
Measured: 3 month
Changes in body mass index after diet changes
Change from baseline InBody - bioelectrical impedance analysis Unit: kg/m2
Measured: 3 month
Changes in glycated hemoglobin after diet changes
Change from baseline Blood test Unit: mmol/mol
Measured: 3 month
Changes in potassium after diet changes
Change from baseline Blood test Unit: mmol/l
Measured: 3 month
Changes in magnesium after diet changes
Change from baseline Blood test Unit: mmol/l
Measured: 3 month
Changes in iron after diet changes
Change from baseline Blood test Unit: mmol/l
Measured: 3 month
Changes in fasting glucose after diet changes
Change from baseline Blood test Unit: mmol/l
Measured: 3 month
Changes in total cholesterol after diet changes
Change from baseline Blood test Unit: mmol/l
Measured: 3 month
Changes in LDL-cholesterol after diet changes
Change from baseline Blood test Unit: mmol/l
Measured: 3 month
Changes in HDL-cholesterol after diet changes
Change from baseline Blood test Unit: mmol/l
Measured: 3 month
Changes in triglycerides after diet changes
Change from baseline Blood test Unit: mmol/l
Measured: 3 month
Changes in lipoprotein(a) after diet changes
Change from baseline Blood test Unit: nmol/l
Measured: 3 month
Changes in IL-6 after diet changes
Change from baseline Blood test Unit: ng/l
Measured: 3 month
Changes in hsCRP after diet changes
Change from baseline Blood test Unit: mg/l
Measured: 3 month
Changes in vitamin B12 after diet changes
Change from baseline Blood test Unit: pmol/l
Measured: 3 month
Changes in 25-hydroxyvitamin D after diet changes
Change from baseline Blood test Unit: nmol/l
Measured: 3 month
Changes in ferritin after diet changes
Change from baseline Blood test Unit: ug/l
Measured: 3 month
Changes in transferin after diet changes
Change from baseline Blood test Unit: g/l
Measured: 3 month
Changes in hemoglobin after diet changes
Change from baseline Blood test Unit: g/l
Measured: 3 month
Changes in body fat after diet changes
Change from baseline InBody - bioelectrical impedance analysis Unit: %
Measured: 3 month
Changes in calcium after diet changes
Change from baseline Blood test Unit: mmol/l
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start20 Jan 2022
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction FirstStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants who agreed to change their dietary habits were randomized in a 1:1 ratio into two intervention groups using stratified block randomization according to diabetes mellitus status and smoking status. Group A followed a diet based on the recommendations of the European Society of Cardiology (ESC), while Group B adopted a strictly plant-based (vegan) diet. Patients who declined dietary modification but agreed to undergo study assessments were included as a parallel, non-intervention control group (Group C), based on patient preference.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radana Dymáčková
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Sponsor-investigator, Radana Dymáčková, St. Anne's University Hospital Brno, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576400
- Sponsor's protocol ID
- 2V/2021
- Acronym
- PBN in IM
- Status last verified
- May 2026
- First submitted
- 8 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot academic study; there is no need to share the IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Diet in the Secondary Prevention of Myocardial Infarction, With a Focus on a Plant-Based Diet
- ClinicalTrials.gov ID
- NCT07576400
- Acronym / sponsor ID
- PBN in IM / 2V/2021
- Conditions
- Myocardial Infarction First
- Keywords
- Myocardial Infarction, Plant based diet, Diet recommended European Society of Cardiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Radana DymáčkováUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 8 May 2026 (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.
The goal of this clinical trial is to evaluate whether short-term dietary interventions can improve cardiometabolic risk factors in patients after myocardial infarction. The study includes adult patients following myocardial infarction.
The main questions it aims to answer are:
- Does adherence to an ESC-recommended diet lead to improvements in lipid profile and body composition compared with no dietary intervention?
- Does a plant-based (vegan) diet lead to similar or greater improvements in cardiometabolic parameters compared with the control group? Researchers will compare the ESC diet group and the plant-based diet group with a control group to assess their effects on body mass index, lipid profile, and inflammatory markers.
Participants will:
- be assigned to one of three groups (ESC diet, plant-based diet, or control),
- receive dietary counselling according to their assigned group (intervention groups),
- follow the assigned dietary pattern for 3 months,
- undergo baseline and follow-up clinical and laboratory assessments, including anthropometric measurements and blood sampling.
Detailed description
This was a single-center, three-arm, controlled, partially randomized interventional pilot study designed to evaluate the feasibility and potential effects of dietary modification in the secondary prevention of myocardial infarction over a three-month period. Participants were recruited between January 2022 and December 2025. The study duration was three months.
Participants who agreed to change their dietary habits were randomized in a 1:1 ratio into two intervention groups using stratified block randomization according to diabetes mellitus status and smoking status. Group A followed a diet based on the recommendations of the European Society of Cardiology (ESC), while Group B adopted a strictly plant-based (vegan) diet.
Patients who declined dietary modification but agreed to undergo study assessments were included as a parallel, non-intervention control group (Group C), based on patient preference.
All participants underwent clinical and laboratory assessments at baseline and at three months, including body composition analysis using bioimpedance (InBody). In the intervention groups, additional scheduled visits were conducted at monthly intervals during the three-month period. At these visits, participants received nutritional counseling from a registered dietitian and completed a three-day dietary record to assess dietary intake and adherence. Participants were additionally allowed to contact the dietitian or the study physician outside the scheduled visits if needed.
Laboratory analyses included lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, lipoprotein(a), triglycerides), glycemic parameters (fasting blood glucose, glycated hemoglobin HbA1c), inflammatory markers (high-sensitivity C-reactive protein (hsCRP) and interleukin-6 (IL-6)), vitamin B12, vitamin D, iron metabolism, complete blood count, and basic biochemical parameters.
Patient recruitment was conducted in collaboration with the coronary care unit of St. Anne's University Hospital Brno (FNUSA). Nutritional counselling was delivered by trained Master's degree nutrition therapy students from the Faculty of Medicine, Masaryk University.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants who agreed to change their dietary habits were randomized in a 1:1 ratio into two intervention groups using stratified block randomization according to diabetes mellitus status and smoking status. Group A followed a diet based on the recommendations of the European Society of Cardiology (ESC), while Group B adopted a strictly plant-based (vegan) diet. Patients who declined dietary modification but agreed to undergo study assessments were included as a parallel, non-intervention control group (Group C), based on patient preference.
| Arm | Type | Receives |
|---|---|---|
| Plant based diet | Experimental | Other: Plant based dietThe intervention arm, in which participants switch to a strictly plant-based (vegan) diet for three months. |
| Diet based on the recommendations of the European Society of Cardiology | Experimental | Other: Diet based on the recommendations of the European Society of CardiologyThe intervention arm, in which participants switch to a diet based on the recommendations of the European Society of Cardiology for three months. |
| Control arm | No intervention | –Patients who declined dietary modification but agreed to undergo study assessments were included as a parallel, non-intervention control group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Myocardial Infarction First
Key exclusion criteria (2 listed)
- Myocardial Infarction Second
- Age under 18
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 |
|---|---|---|
| Plant based dietChange dietary habits for tree months | Other | Plant based diet |
| Diet based on the recommendations of the European Society of CardiologyChange dietary habits for tree months | Other | Diet based on the recommendations of the European Society of Cardiology |
Primary outcome
Percentage of participants enrolled in the study
Time frame: 48 months
In percentage terms, the number of patients contacted and the proportion of those who were subsequently enrolled.
Percentage of participants completed the study
Time frame: 3 month
Percentage of the enrolled patients completed the study.
25 secondary outcomes
Changes in weight after diet changes
Time frame: 3 months
Changes in viceral fat area after diet changes
Time frame: 3 month
Changes in skeletal muscle mass after diet changes
Time frame: 3 month
Changes in body fat mass after diet changes
Time frame: 3 month
Changes in total body water after diet changes
Time frame: 3 month
Changes in body mass index after diet changes
Time frame: 3 month
Changes in glycated hemoglobin after diet changes
Time frame: 3 month
Changes in potassium after diet changes
Time frame: 3 month
Changes in magnesium after diet changes
Time frame: 3 month
Changes in iron after diet changes
Time frame: 3 month
Changes in fasting glucose after diet changes
Time frame: 3 month
Changes in total cholesterol after diet changes
Time frame: 3 month
Changes in LDL-cholesterol after diet changes
Time frame: 3 month
Changes in HDL-cholesterol after diet changes
Time frame: 3 month
Changes in triglycerides after diet changes
Time frame: 3 month
Changes in lipoprotein(a) after diet changes
Time frame: 3 month
Changes in IL-6 after diet changes
Time frame: 3 month
Changes in hsCRP after diet changes
Time frame: 3 month
Changes in vitamin B12 after diet changes
Time frame: 3 month
Changes in 25-hydroxyvitamin D after diet changes
Time frame: 3 month
Changes in ferritin after diet changes
Time frame: 3 month
Changes in transferin after diet changes
Time frame: 3 month
Changes in hemoglobin after diet changes
Time frame: 3 month
Changes in body fat after diet changes
Time frame: 3 month
Changes in calcium after diet changes
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No. This is a pilot academic study; there is no need to share the IPD with other researchers.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant based diet and Diet based on the recommendations of the European Society of Cardiology in people with Myocardial Infarction First, run by Radana Dymáčková at 1 site in Czechia.
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 1 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: finished, as of the sponsor's last update on 8 May 2026. 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of participants enrolled in the study (time frame: 48 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?
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 8 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.