- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07427199
Effect of Digitally Supported Medical Nutrition Therapy on Left Ventricular Ejection Fraction in Patients With ST-Elevation Myocardial Infarction
February 16, 2026 updated by: Saglik Bilimleri Universitesi
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sena Yücel
- Phone Number: +90 530 118 8468
- Email: senayucel633@gmail.com
Study Contact Backup
- Name: Ziya Erokay Metin, Doç.Dr.
- Email: metinziya.erokay@sbu.edu.tr
Study Locations
-
-
Atakum
-
Samsun, Atakum, Turkey (Türkiye)
- Recruiting
- Ondokuz Mayıs Üniversitesi Tıp Fakültesi Hastanesi
-
Contact:
- Sena Yücel
- Phone Number: +90 530 118 8468
- Email: senayucel633@gmail.com
-
Contact:
- Ziya Erokay Metin
- Email: metinziya.erokay@sbu.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard Dietary Care / Control
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.
|
|
|
Experimental: Digital Content-Supported Nutrition Therapy
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 1 month, 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 30, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
February 16, 2026
First Submitted That Met QC Criteria
February 16, 2026
First Posted (Actual)
February 23, 2026
Study Record Updates
Last Update Posted (Actual)
February 23, 2026
Last Update Submitted That Met QC Criteria
February 16, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
Chinese PLA General HospitalCompletedST Elevation (STEMI) Myocardial InfarctionChina
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Second Affiliated Hospital of Nanchang UniversityZhuZhou Central Hospital; First Affiliated Hospital of Gannan Medical University and other collaboratorsNot yet recruitingSTEMI - ST Elevation Myocardial Infarction | NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)
-
Myomed Technology (Shaoxing) Co., Ltd.Not yet recruitingSTEMI - ST Elevation Myocardial InfarctionChina
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Assiut UniversityUnknownST-segment Elevation Myocardial Infarction (STEMI)
Clinical Trials on Digital Content-Supported Medical Nutrition Therapy
-
Hong Kong Metropolitan UniversityQueen Mary Hospital, Hong KongRecruiting
-
The University of Texas Medical Branch, GalvestonAmerican Diabetes AssociationRecruitingDiabetes Mellitus, Type 2United States
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University of Alabama, TuscaloosaAcademy of Nutrition and DieteticsRecruitingBrain InjuriesUnited States
-
Hugo Mendieta ZeronFogarty International Center of the National Institute of Health; Instituto...CompletedGestational Weight GainMexico
-
Ariel UniversitySheba Medical Center; Soroka University Medical CenterCompletedCardiovascular Diseases | Acute MIIsrael
-
Instituto Nacional de Perinatologia Isidro Espinosa...CompletedType 2 Diabetes | Gestational DiabetesMexico
-
Academy of Nutrition and DieteticsActive, not recruiting
-
The Third Xiangya Hospital of Central South UniversityUnknownDiabetes, GestationalChina
-
Weill Medical College of Cornell UniversityTerminated
-
Hacettepe UniversityNot yet recruitingFibromyalgia | Fibromyalgia Syndrome, Primary | Fibromyalgia (FM)Turkey (Türkiye)