ISRCTN38736987已完成未知
A randomised, double-blind, placebo-controlled trial assessing the safety and efficacy of intracoronary NITRITE infusion during Acute Myocardial Infarction
Barts and The London NHS Trust (UK)0 个研究点目标入组 80 人开始时间: 2013年1月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
- 2013 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/23550096 2. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25512434 (added 27/08/2019) 3. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/27683405
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients aged at least 18 years, upper age limit 80 years, male and female
- •2. Acute ST-elevation myocardial infarction with ECG showing at least 2 mm of ST segment elevation in 2 or more limb leads or 1mm in 2 or more contiguous chest leads, or new left bundle branch block
- •3. Haemodynamically stable
- •4. Estimated symptom to balloon or aspiration time < 6 hours
- •5. A signed and dated written informed consent prior to admission to the study
- •6. Angiographicallly
- •6.1. Primary Percutaneous Coronary Intervention (PPCI) indicated for revascularisation
- •6.2. Single epicardial artery to be treated
- •6.3. Expected ability to use the over the wire balloon for delivery of nitrite
排除标准
- •1. Patients already on nitrate Treatment (Nicorandil, ISMN)
- •2. Previous history of myocardial infarction (MI) or systolic dysfunction
- •3. Previous coronary artery bypass surgery (CABG)
- •4. Subjects presenting with cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring inotropes or emergency IntraAortic
- •Balloon Pump (IABP) for hypotension treatment) or cardiopulmonary resuscitation
- •5. Current diagnosis of or treatment for malignancy, other than non-melanoma skin cancer
- •6. Current life-threatening condition other than vascular disease that may prevent a subject completing the study
- •7. Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication
- •8. Patients considered unsuitable to participate by the research team (e.g., due to medical reasons, laboratory abnormalities, or subject?s unwillingness to comply with all study-related procedures)
- •9. Severe acute infection, or significant trauma (burns, fractures)
- •10. Pregnancy
- •11. Contraindications tocardiac magnetic resonance (CMR) scanning
- •11.1. Pacemakers, intracranial clips or other metal implants or foreign bodies
- •11.2. Claustrophobia
- •11.3. Renal Failure (eGFR<30mls/min)
- •12. History of alcohol or drug abuse within the past 6 months
- •13. History of congenital methaemoglobinaemia
- •14. Angiographically
- •14.1. Severe vessel tortuosity, diffuse disease or severe calcification is present which may impede successful delivery of the over the wire balloon
研究者
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