A randomised, double-blind, placebo-controlled trial assessing the safety and efficacy of intracoronary NITRITE infusion during Acute Myocardial Infarctio

Not Applicable

Completed

• Conditions: Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Atherothrombosis; Circulatory System; Acute myocardial infarction

• Registration Number: ISRCTN38736987
• Lead Sponsor: Barts and The London NHS Trust (UK)

Brief Summary

1. 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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-23
• Study Completion: 2014-02-10
• Last Update Posted: 16 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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)
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Creatine Kinase AUC first 48 hours after PPCI

Secondary Outcome Measures

Name	Time	Method
<br> 1. Infarct size on CMR; Timepoint(s): 48 hours and 6 months<br> 2. Myocardial salvage index (MSI) on CMR; Timepoint(s): 48 hours<br> 3. Troponin T AUC; Timepoint(s): 1st 48 hours after PPCI<br>