A Pilot Randomized Controlled Trial of Intravenous N-acetyl Cysteine in Patients Undergoing Pharmaco-invasive Reperfusion Early After an ST-segment Elevation Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Myocardial infarct size
研究概览
简要总结
The PANACEA trial is an investigator-initiated prospective, single-center, two-arm, non-blinded pilot randomized controlled trial of high-dose IV N-Acetylcysteine therapy used as an adjunct to pharmaco-invasive reperfusion in patients presenting early after a large STEMI.
详细描述
Patients presenting with ST-segment elevation myocardial infarction within 3 hours of symptom onset and satisfying all of the inclusion criteria after informed consent would be randomly allocated to either intravenous N-Acetylcysteine or standard treatment using a 1:1 allocation ratio. Those randomized to IV N-Acetylcysteine would be administered a bolus of 1200 mg over 0.5 hours (in 5% Dextrose) followed by 600mg/hour for the remaining 47.5 hours (in 5% dextrose). A total N-acetylcysteine dose of 29.7 grams is administered over 48 hours. The infusion is continued during the primary percutaneous coronary intervention. Patients would be followed up for a minimum of 90 days. The primary clinical endpoint will be myocardial infarct size measured by late gadolinium enhancement CMR imaging at 3-5 days from first medical contact. Primary feasibility outcome will be the rate of recruitment, the number of patients undergoing cardiac MRI within the stipulated time frame, and completeness of the study data collection.
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
- Single (Outcomes Assessor)
盲法说明
The clinical outcomes assessor reading the cardiac MRI would be blinded to the study arm allotment.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with STEMI within 3 hours of symptom onset and satisfying all of the following criteria:
- •Patient age ≥ 18 years
- •Have received thrombolysis, with intend to pursue a pharmaco-invasive reperfusion strategy. Onset of chest pain to reperfusion time of < 3hrs.
- •STEMI involving anterior and/or inferior wall
- •An absence of baseline Q-waves on the initial ECG: The presence of Q waves defined at baseline using the Selvester QRS screening criteria
- •Have a high-risk STEMI ECG defined as:
- •≥2mm ST-segment elevation in 2 anterior or lateral leads; or
- •≥2 mm ST-segment elevation in 2 inferior leads coupled with ST-segment depression in 2 contiguous anterior leads for a total ST-segment deviation of ≥4 mm
排除标准
- •Previous myocardial infarction
- •Known to have moderate to severe LV systolic dysfunction (LV EF< 45%)
- •Known allergy to thrombolytic therapy or NAC
- •Presence of left bundle branch block
- •Cardiogenic shock (defined as systolic blood pressure of < 90mm Hg, for at least 30 minutes, not responsive to fluid resuscitation)
- •Permanent pacemaker or cardioverter defibrillator implanted previously
- •Patients with contra-indications to thrombolytic therapy
- •Patients with loss of consciousness or confusion
- •Patients with known chronic kidney disease (GFR < 30ml/min/m2) or on dialysis
- •Current pregnancy
- •Planned therapy with primary PCI
研究组 & 干预措施
Intravenous N-Acetylcysteine arm
On arrival at the recruiting hospital, eligible and consenting STEMI patients randomly allocated to the experimental arm would be administered an intravenous N-Acetylcysteine bolus of 1200 mg over 0.5 hours (in 5% Dextrose) followed by 600mg/hour for the remaining 47.5 hours (in 5% dextrose). A total N-acetylcysteine dose of 29.7 grams is administered over 48 hours.
干预措施: Intravenous N-Acetylcysteine (Drug)
结局指标
主要结局
Myocardial infarct size
时间窗: 3-5 days after first medical contact
The primary clinical endpoint will be myocardial infarct size measured by late gadolinium enhancement CMR imaging at 3-5 days from first medical contact.
Feasibility outcomes
时间窗: Assessed at the end of the study
Primary feasibility outcomes would include the rate of recruitment, the number of patients undergoing cardiac MRI within the stipulated time frame, and completeness of the study data collection.
次要结局
- Myocardial salvage(3-5 days after infarction)
- Creatine kinase MB area under the curve(24 hours after admission)
- Von Willebrand factor fragmentation(At the time of angiography, assessed up to 7 days from admission)
- Allergic reactions(From time of randomization, upto 48 hours)
- Left ventricular ejection fraction(3-5 days after infarction)
- ST-segment elevation resolution(90-minutes after thrombolysis)
- TIMI frame count in infarct related artery(During index coronary angiogram which will be performed within 24 hours of admission)
- Bleeding(From time of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 90 days)