ISRCTN38736987
Completed
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 sites80 target enrollmentJanuary 23, 2013
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Topic: Cardiovascular
- Sponsor
- Barts and The London NHS Trust (UK)
- Enrollment
- 80
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
- 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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