Myocardial InfarctionNCT07624240
Educational Dietary Intervention in Early Cardiac Rehabilitation After Myocardial Infarction
A study testing Dietary education in people with Myocardial Infarction and Cardiac Rehabilitation, run by Medical University of Lublin at 1 site in Poland.
Trial summary
The trial is designed to assess whether individualized nutritional education provides additional benefit beyond standard early cardiac rehabilitation in patients after myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Cardiac Rehabilitation
- What is being tested?
- Dietary education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2024to 31 Mar 2026
- 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
- age ≥18 years,
- recent myocardial infarction treated according to standard clinical practice,
- qualification for early cardiac rehabilitation after myocardial infarction,
- clinically stable status at enrollment,
- ability to participate in standard rehabilitation and additional nutritional education,
- ability to complete dietary and nutritional knowledge questionnaires,
- ability to undergo anthropometric measurements and bioelectrical impedance analysis,
- provision of written informed consent.
Who cannot join
- refusal or inability to provide informed consent,
- contraindications to cardiac rehabilitation,
- severe clinical instability, including unstable hemodynamic status, recurrent ischemia, uncontrolled arrhythmia, or decompensated heart failure, preventing participation in rehabilitation;
- severe cognitive, psychiatric, or communication limitations preventing participation in educational sessions or reliable questionnaire completion,
- conditions preventing valid body composition assessment (according to device producer e.g. large metal implants).
Trial locations and contacts
1 site in 1 country.
About this study
The trial is designed to assess whether individualized nutritional education provides additional benefit beyond standard early cardiac rehabilitation in patients after myocardial infarction. Patients referred for cardiac rehabilitation after myocardial infarction are randomized to a control group receiving standard rehabilitation care or to an intervention group receiving standard care plus structured personalized dietary education. The educational intervention is tailored to baseline dietary habits, nutritional knowledge, and adherence to cardioprotective dietary recommendations. Outcomes include changes in diet quality, adherence to the Mediterranean diet, nutritional knowledge, anthropometric measures, and bioelectrical impedance analysis-derived body composition parameters. The study will evaluate the feasibility and effectiveness of integrating individualized dietary education into early cardiac rehabilitation after myocardial infarction.
- Conditions
- Myocardial Infarction, Cardiac Rehabilitation
- Being tested
- Dietary education
- Keywords
- myocardial infarction, cardiac rehabiltiation, dietary edutation
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary educationBehavioural
Participants in the intervention group receive standard early cardiac rehabilitation supplemented with individualized dietary counselling provided by a trained dietitian. The counselling is tailored to baseline dietary habits, nutritional knowledge, cardiovascular risk factors, nutritional status, comorbidities, and body composition. The intervention focuses on improving adherence to cardioprotective and Mediterranean-style dietary recommendations, including higher intake of vegetables, fruit, whole-grain products, legumes, nuts, fish, and unsaturated fats, and reduced intake of saturated fats, highly processed foods, sweets, sugar-sweetened beverages, and excess salt. The intervention includes assessment of current diet, identification of key dietary errors, practical recommendations, and individualized nutrition-related goals during cardiac rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Additional education | Experimental | Not described Receives: Behavioral: Dietary education |
| Standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet quality
Overall diet quality assessed with Diet Quality Index score derived from Dietary Habits and Nutrition Beliefs Questionnaire
Measured: 3 months
Dietary knowledge
Diet knowledge score derived from Dietary Habits and Nutrition Beliefs Questionnaire
Measured: 3 months
Body mass
Measured: 3 months
Fat mass
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jun 2024
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
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 Myocardial InfarctionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Popiołek-Kalisz, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624240
- Sponsor's protocol ID
- KE-0254/86/05/2024
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Popiolek-Kalisz J, Mazur M, Perone F. The Role of Dietary Education in Cardiac Rehabilitation. Nutrients. 2025 Mar 19;17(6):1082. doi: 10.3390/nu17061082.
PubMed 40292477Popiolek-Kalisz J. The role of nutrition in cardiovascular protection - personalized versus universal dietary strategies. Trends Cardiovasc Med. 2026 Feb;36(2):84-90. doi: 10.1016/j.tcm.2025.08.007. Epub 2025 Aug 22.
PubMed 40850360
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Dietary Intervention in Early Cardiac Rehabilitation After Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07624240
- Acronym / sponsor ID
- KE-0254/86/05/2024
- Conditions
- Myocardial Infarction, Cardiac Rehabilitation
- Keywords
- myocardial infarction, cardiac rehabiltiation, dietary edutation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 3 Jun 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 trial is designed to assess whether individualized nutritional education provides additional benefit beyond standard early cardiac rehabilitation in patients after myocardial infarction. Patients referred for cardiac rehabilitation after myocardial infarction are randomized to a control group receiving standard rehabilitation care or to an intervention group receiving standard care plus structured personalized dietary education. The educational intervention is tailored to baseline dietary habits, nutritional knowledge, and adherence to cardioprotective dietary recommendations. Outcomes include changes in diet quality, adherence to the Mediterranean diet, nutritional knowledge, anthropometric measures, and bioelectrical impedance analysis-derived body composition parameters. The study will evaluate the feasibility and effectiveness of integrating individualized dietary education into early cardiac rehabilitation after myocardial infarction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Additional education | Experimental | Behavioral: Dietary education |
| Standard of care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age ≥18 years,
- recent myocardial infarction treated according to standard clinical practice,
- qualification for early cardiac rehabilitation after myocardial infarction,
- clinically stable status at enrollment,
- ability to participate in standard rehabilitation and additional nutritional education,
Key exclusion criteria (5 listed)
- refusal or inability to provide informed consent,
- contraindications to cardiac rehabilitation,
- severe clinical instability, including unstable hemodynamic status, recurrent ischemia, uncontrolled arrhythmia, or decompensated heart failure, preventing participation in rehabilitation;
- severe cognitive, psychiatric, or communication limitations preventing participation in educational sessions or reliable questionnaire completion,
- conditions preventing valid body composition assessment (according to device producer e.g. large metal implants).
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 educationParticipants in the intervention group receive standard early cardiac rehabilitation supplemented with individualized dietary counselling provided by a trained dietitian. The counselling is tailored to baseline dietary habits, nutritional knowledge, cardiovascular risk factors, nutritional status, comorbidities, and body composition. The intervention focuses on improving adherence to cardioprotective and Mediterranean-style dietary recommendations, including higher intake of vegetables, fruit, whole-grain products, legumes, nuts, fish, and unsaturated fats, and reduced intake of saturated fats, highly processed foods, sweets, sugar-sweetened beverages, and excess salt. The intervention includes assessment of current diet, identification of key dietary errors, practical recommendations, and individualized nutrition-related goals during cardiac rehabilitation. | Behavioural | Additional education |
Primary outcome
Diet quality
Time frame: 3 months
Overall diet quality assessed with Diet Quality Index score derived from Dietary Habits and Nutrition Beliefs Questionnaire
Dietary knowledge
Time frame: 3 months
Diet knowledge score derived from Dietary Habits and Nutrition Beliefs Questionnaire
Body mass
Time frame: 3 months
Fat mass
Time frame: 3 months
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 5 Jun 2026.
- Background: PubMed 40292477Popiolek-Kalisz J, Mazur M, Perone F. The Role of Dietary Education in Cardiac Rehabilitation. Nutrients. 2025 Mar 19;17(6):1082. doi: 10.3390/nu17061082.
- Background: PubMed 40850360Popiolek-Kalisz J. The role of nutrition in cardiovascular protection - personalized versus universal dietary strategies. Trends Cardiovasc Med. 2026 Feb;36(2):84-90. doi: 10.1016/j.tcm.2025.08.007. Epub 2025 Aug 22.
- Individual participant dataSharing planned: Yes
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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.
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 Dietary education in people with Myocardial Infarction and Cardiac Rehabilitation, run by Medical University of Lublin 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 8 inclusion and 5 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 5 Jun 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 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?
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?
Diet quality (time frame: 3 months). The study lists 4 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 NCT07624240, 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 5 Jun 2026.