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临床试验/NCT07427199
NCT07427199招募中不适用

Effect of Digitally Supported Medical Nutrition Therapy on Left Ventricular Ejection Fraction in Patients With ST-Elevation Myocardial Infarction: A Randomized Controlled Trial

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年12月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Left Ventricular Ejection Fraction (LVEF)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Echocardiography assessments are performed by a cardiologist blinded to group assignment.

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Digital Content-Supported Medical Nutrition Therapy (Behavioral)

结局指标

主要结局

Left Ventricular Ejection Fraction (LVEF)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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