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临床试验/NCT05957887
NCT05957887招募中3 期

Short and Intermediate Term Effect of Dapagliflozin on Left Ventricular Remodeling in Anterior STEMI Patients

Mohamed Nabil Elkholy1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年4月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
number of patients with acute ST elevation anterior myocardial infarction who took Dapagliflozin who shows improvement in cardiac remodeling (assessed by 2D echocardiogram (by measuring GLS)

研究概览

简要总结

Methodology This study will enroll (120) patients presenting with acute anterior STEMI who will undergo early reperfusion presenting at Helwan University Hospitals and Ain Shams University Hospitals.

Diagnosis of STEMI will be based on:

Sustained ST-segment elevation of at least 1 mm in at least 2 contiguous leads or new/presumably new left bundle branch block, plus >Typical anginal pain, or > diagnostic levels of serum cardiac biomarkers, or > imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

They will be subdivided into two (2) groups according to Dapagliflozin intake into:

  • Group A:

Patients with diabetes mellitus (DM) (60) patients, they will be further subdivided into 2 subgroups:

Group A1:

30 patients will receive Dapagliflozin in addition to standard anti-ischemic and anti-diabetic treatment.

Group A2:

30 patients will receive standard anti-ischemic and antidiabetic treatment (Dapagliflozin not included).

  • Group B:

Patients without DM (60) patients, subdivided to 2 subgroups:

Group B1:

30 patients will receive standard anti-ischemic treatment.

Group B2:

30 patients will receiv up e standard anti-ischemic treatment and Dapagliflozin.

Methodology in details:

The study patients will undergo early reperfusion according to the recent practice guidelines and the local hospital policy in managing ST elevation MI patients. Echocardiography will be performed twice: within 48 hours of admission and 3 months following the index event.

Management:

Twelve-lead electrocardiogram will be recorded at baseline and 30-min post-procedure. The ST-segment changes will be evaluated in the single lead with the most prominent ST-segment elevation before intervention. The ST-segment elevation will be measured to the nearest 0.5 mm at 60 ms after the J point. Significant ST segment resolution (STR) is defined as a reduction in ST-segment elevation of 50% after 30 min of infarct artery recanalization.

Immediately before the procedure, patients will receive aspirin (300 mg), ticagrelor (180 mg) or clopidogrel (600 mg) depending on availability. Adjunctive pharmacological treatment during the procedure will include:

  1. Unfractionated heparin as an initial bolus of 70 U/kg and additional boluses during the procedure to achieve an activated clotting time of 250 to 350 s (200 to 250 s if Glycoprotein IIb/IIIa (GPIIb/IIIa) antagonist is used). Heparin will be discontinued at the end of percutaneous coronary intervention.
  2. The use of a GPIIb/IIIa antagonist during the procedure, primary PCI technique, indications, and methods of thrombectomy if indicated will be done under the regulations of the local hospital policy and the most recent practice guidelines.

详细描述

Introduction

Coronary Heart Disease (CHD) is one of the leading causes of death worldwide, with an estimated 7.4 million deaths in 2015.The main clinical presentation of coronary heart disease is myocardial infarction (MI). It is responsible for over 15% of mortality each year.

Myocardial infarction is usually due to thrombotic occlusion of a coronary vessel caused by rupture of a vulnerable plaque. Ischemia induces profound metabolic and ionic perturbations in the affected myocardium and causes rapid depression of systolic function.

Early reperfusion is a key strategy to decrease mortality and major cardiovascular events in STEMI care. Nowadays the best method of reperfusion in acute MI is primary PCI, the benefit of primary PCI is time dependent. The infarction-related artery (IRA) must be opened early, consistently, and thoroughly in order to effectively restore myocardial perfusion. The shorter the time from symptom onset to reperfusion, the greater the patient will benefit.

Myocardial contractility requires adequate myocardial perfusion and previous studies have demonstrated that a 30-35% decrease in myocardial blood flow or a reduction in perfusion pressure at rest causes regional reversible myocardial wall motion abnormalities. After coronary occlusion, myocardial perfusion may be depressed despite successful restoration of flow in the epicardial vessel, which may have important implications on the future of left ventricular (LV) function and patient prognosis.

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • STEMI with time from symptom onset of <48 hours duration.
  • Capable of giving signed informed consent.

排除标准

  • Patients with a history of old myocardial infarction.
  • Patients with a history of previous coronary artery bypass surgery (CABG).
  • Hemodynamically unstable patients.
  • Patients with suboptimal echocardiographic images
  • Patients with any cardiac rhythm other than sinus rhythm.
  • Unsuccessful angiographic reperfusion (Thrombolysis In Myocardial Infarction [TIMI] flow grade <2).
  • Patients with renal dysfunction. (GFR<30mmol/L).
  • Patients who have recently undergone immunosuppressive therapy.
  • Patients with a history of recurrent urinary tract infections.
  • Patients who are known to be allergic to SGLT-2 inhibitors.
  • Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization.
  • Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
  • Any other non cardiovascular diseases, such as active malignancy requiring treatment at the time of screening or with a life expectancy of fewer than two years based on the investigator´s clinical judgment.
  • Currently on treatment with a sodium-glucose co-transporter 2 inhibitor (SGLT2-inhibitors).

研究组 & 干预措施

Dapagliflozin use in diabetic patients with anterior STEMI

Active Comparator

干预措施: Dapagliflozin (Drug)

Dapagliflozin use in non-diabetic patients with anterior STEMI

Active Comparator

干预措施: Dapagliflozin (Drug)

结局指标

主要结局

number of patients with acute ST elevation anterior myocardial infarction who took Dapagliflozin who shows improvement in cardiac remodeling (assessed by 2D echocardiogram (by measuring GLS)

时间窗: 18 months

GLS is global longitudinal strain which is measured by 2D echocardiogram (normal GLS \> -20) the absolute value of GLS is decreased in impaired LV systolic function

次要结局

  • Assess of cardiac toxicity in patients presented with acute ST elevation anterior myocardial infarction(18 months)

研究者

发起方
Mohamed Nabil Elkholy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Nabil Elkholy

Specialist, Cardiology Department, Principle Investigator

Helwan University

研究点 (1)

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