The Effect of Coenzyme Q10 Supplementation on Global Longitudinal Strain Values in Acute ST Segment Elevation Myocardial Infarction Patients Treated With Primary Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Improvements in Global longitudinal strain
研究概览
简要总结
Left ventricular remodeling can still occur after primary percutaneous coronary intervention (PCI). Global longitudinal strain (GLS) assessment has been used as a predictor of left ventricular remodeling. Coenzyme Q10 is known for its anti-inflammatory and antioxidant properties, which may help reduce cardiac remodeling. This study aims to determine the effect of CoQ10 administration after myocardial infarction as an adjunct to standard therapy on left ventricular remodeling, assessed through changes in GLS values.
Researchers will compare Coenzyme Q10 to a placebo to see if Coenzyme Q10 has a greater effect on improving left ventricular GLS values in patients with ST-Elevation Myocardial Infarction undergoing primary percutaneous coronary intervention.
详细描述
This is a randomized, double blind study with 2 treatment groups. Participants diagnosed with Acute STEMI post primary PCI who meet the inclusion criteria and no exclusion criteria are given an explanation regarding the research and additional therapy that will be given, then informed consent is requested. Participants will be randomized to one of the two treatment groups by chance. Patients randomized to the first group will receive coenzyme Q10 100mg/12hours. Patients randomized to the other treatment group will receive a placebo. It is expected that the patients of the treatment group with the coenzyme Q10 will have a greater improvement of their GLS.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
participant, care Provider, and investigator will not know either they include in treatment or control group
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 21 - 80 years
- •Agree to participate in the study
- •Patients with a diagnosis of Acute Myocardial Infarction with ST-Segment Elevation (AMI-STE) with onset < 12 hours who underwent primary percutaneous coronary intervention (PCI)
- •Successful primary PCI on the culprit lesion (residual stenosis < 20%, TIMI flow III)
- •Received standard medication therapy according to guidelines (Guideline-Directed Medical Therapy; GDMT) achieved during hospitalization
- •Sinus rhythm at the time of echocardiographic examination
排除标准
- •Patients who routinely consume CoQ10 prior to the study
- •Patients with hemodynamic conditions of Killip class III-IV and NYHA class III-IV
- •Patients with a history of previous acute myocardial infarction
- •Patients with a history of previous PCI or fibrinolytic therapy
- •Patients with a history of previous coronary artery bypass surgery
- •Patients with heart valve disease greater than moderate severity
- •Patients receiving warfarin therapy
- •Patients with a diagnosis of isolated right ventricular infarction
- •Patients with inadequate echocardiographic image quality (poor echo window)
研究组 & 干预措施
Group A (Oral Coenzyme Q10)
Experimental: Group A (Oral Coenzyme Q10) Participants who received standard treatment plus Coenzyme Q10 100 mg / 12 hours orally for up to 8 weeks.
Intervention/Treatment Drug: Oral Coenzyme Q10
* Participants will be randomized into group receiving either oral Coenzyme Q10 or placebo for up to 8 weeks
干预措施: Coenzyme Q 10 (Drug)
Group B (Placebo)
Placebo Comparator: Group B (Placebo) Participants who received standard treatment plus Placebo / 12 hours orally for up to 8 weeks.
Intervention/Treatment Drug: Placebo
* Participants will be randomized into group receiving either oral Coenzyme Q10 or placebo for up to 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Improvements in Global longitudinal strain
时间窗: at 8 weeks follow up
GLS value was evaluated pre and post intervention. Pre intervention GLS were examined within the first 24 hour after PPCI, GLS post intervention at 8 weeks follow up GLS assesed with Epiq 7C ultrasound machine manufactured by Philips Medical Systems, the investigators conducted two-dimentional speckle-tracking investigations. These studies utilized QLAB/automated cardiac motion quantification (ACMQ) version 10.85 and QLAB/LV auto-strain version 12.0, both developed by Philips Healthcare. Three sequential cardiac cycles of apical 4, 2, and 3 chamber view images were stored using all scanners with the best machine settings and frame rates 50-70 frames per second for the purpose of measuring strain using speckle tracking echocardiography.
次要结局
未报告次要终点
研究者
Ilham Uddin, MD
Principal Investigator
Universitas Diponegoro