ST-elevation Myocardial Infarction (STEMI)NCT07427199
Effect of Digitally Supported Medical Nutrition Therapy on Left Ventricular Ejection Fraction in Patients With ST-Elevation Myocardial Infarction
A study testing Digital Content-Supported Medical Nutrition Therapy in people with ST-elevation Myocardial Infarction (STEMI), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study is designed to investigate the effect of a nutrition program supported by digital content on heart function in patients who have experienced a heart attack with ST-elevation. Participants will receive personalized dietary guidance and digital support materials for three months. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- ST-elevation Myocardial Infarction (STEMI)
- What is being tested?
- Digital Content-Supported Medical Nutrition Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 19-65 who have fully completed the voluntary consent form
- Being of normal weight (BMI 18.5-24.9 kg/m²) or obese (30-34.99 kg/m²)
- Having suffered a heart attack with ST elevation (STEMI)
- To be enrolled in the study within the first 72 hours after hospital admission
- To be willing to participate in a follow-up period of at least 3 months
Who cannot join
- Those who did not sign the voluntary consent form
- Individuals aged over 65
- Weight loss exceeding 5% in the last 3 months
- Those with malignancy, chronic renal failure or severe systemic disease
- Patients unable to complete the questionnaires due to severe cognitive impairment
- Those who have previously received nutrition education or eating awareness training
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ziya Erokay Metin, Doç.Dr. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ondokuz Mayıs Üniversitesi Tıp Fakültesi Hastanesi
Samsun, Atakum
Sena Yücel, +90 530 118 8468, senayucel633@gmail.com
Ziya Erokay Metin, metinziya.erokay@sbu.edu.tr
About this study
Official title: Effect of Digitally Supported Medical Nutrition Therapy on Left Ventricular Ejection Fraction in Patients With ST-Elevation Myocardial Infarction: A Randomized Controlled Trial
This study is designed to investigate the effect of a nutrition program supported by digital content on heart function in patients who have experienced a heart attack with ST-elevation. Participants will receive personalized dietary guidance and digital support materials for three months. The main goal is to determine whether this digital support materials can improve heart pumping function (measured by left ventricular ejection fraction). Participation involves following the dietary program and undergoing heart function measurements at the beginning, after one months and after three months.
- Being tested
- Digital Content-Supported Medical Nutrition Therapy
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Content-Supported Medical Nutrition TherapyBehavioural
Participants receive a personalized medical nutrition therapy program supported by digital content. The program includes educational materials, meal planning guides, and remote support. The intervention lasts 3 months, with follow-up visits at baseline, 1 month, and 3 months. Heart function (LVEF) will be measured at each time point.
| Study group | Role | What they receive |
|---|---|---|
| Standard Dietary Care / Control | No intervention | Participants in this group receive standard dietary care as routinely provided to patients after ST-elevation myocardial infarction, without additional digital content support. Heart function (LVEF) will be measured at baseline, 1 month, and 3 months. |
| Digital Content-Supported Nutrition Therapy | Experimental | Participants in this group receive a personalized medical nutrition therapy program supported by digital content, including educational materials, meal planning guides, and remote support. The program lasts 3 months, with follow-up visits at baseline, 1 month, and 3 months. Heart function (LVEF) will be measured at each time point. Receives: Behavioral: Digital Content-Supported Medical Nutrition Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction (LVEF)
Left ventricular ejection fraction will be measured using echocardiography at baseline, 1 month, and 3 months to evaluate the effect of digital content-supported medical nutrition therapy.
Measured: Baseline, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start30 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Model description
- Participants are randomly assigned in a parallel design to either the intervention group receiving digital content-supported medical nutrition therapy or the control group receiving standard dietary care. Heart function (LVEF) will be measured at baseline, at 1 month, and at 3 months of follow-up.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayis University Training and Research Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427199
- Sponsor's protocol ID
- 2025/012
- Status last verified
- Jan 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Digitally Supported Medical Nutrition Therapy on Left Ventricular Ejection Fraction in Patients With ST-Elevation Myocardial Infarction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07427199
- Acronym / sponsor ID
- 2025/012
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Ondokuz Mayis University Training and Research Hospital
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Feb 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.
This study is designed to investigate the effect of a nutrition program supported by digital content on heart function in patients who have experienced a heart attack with ST-elevation. Participants will receive personalized dietary guidance and digital support materials for three months. The main goal is to determine whether this digital support materials can improve heart pumping function (measured by left ventricular ejection fraction). Participation involves following the dietary program and undergoing heart function measurements at the beginning, after one months and after three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a parallel design to either the intervention group receiving digital content-supported medical nutrition therapy or the control group receiving standard dietary care. Heart function (LVEF) will be measured at baseline, at 1 month, and at 3 months of follow-up.
| Arm | Type | Receives |
|---|---|---|
| Standard Dietary Care / Control | No intervention | –Participants in this group receive standard dietary care as routinely provided to patients after ST-elevation myocardial infarction, without additional digital content support. Heart function (LVEF) will be measured at baseline, 1 month, and 3 months. |
| Digital Content-Supported Nutrition Therapy | Experimental | Behavioral: Digital Content-Supported Medical Nutrition TherapyParticipants in this group receive a personalized medical nutrition therapy program supported by digital content, including educational materials, meal planning guides, and remote support. The program lasts 3 months, with follow-up visits at baseline, 1 month, and 3 months. Heart function (LVEF) will be measured at each time point. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals aged 19-65 who have fully completed the voluntary consent form
- Being of normal weight (BMI 18.5-24.9 kg/m²) or obese (30-34.99 kg/m²)
- Having suffered a heart attack with ST elevation (STEMI)
- To be enrolled in the study within the first 72 hours after hospital admission
- To be willing to participate in a follow-up period of at least 3 months
Key exclusion criteria (6 listed)
- Those who did not sign the voluntary consent form
- Individuals aged over 65
- Weight loss exceeding 5% in the last 3 months
- Those with malignancy, chronic renal failure or severe systemic disease
- Patients unable to complete the questionnaires due to severe cognitive impairment
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 |
|---|---|---|
| Digital Content-Supported Medical Nutrition TherapyParticipants receive a personalized medical nutrition therapy program supported by digital content. The program includes educational materials, meal planning guides, and remote support. The intervention lasts 3 months, with follow-up visits at baseline, 1 month, and 3 months. Heart function (LVEF) will be measured at each time point. | Behavioural | Digital Content-Supported Nutrition Therapy |
Primary outcome
Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline, 1 month, 3 months
Left ventricular ejection fraction will be measured using echocardiography at baseline, 1 month, and 3 months to evaluate the effect of digital content-supported medical nutrition therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- 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.
Ziya Erokay Metin, Doç.Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Content-Supported Medical Nutrition Therapy in people with ST-elevation Myocardial Infarction (STEMI), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Feb 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sena Yücel (+90 530 118 8468, senayucel633@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Ejection Fraction (LVEF) (time frame: Baseline, 1 month, 3 months). 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 23 Feb 2026.