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

• Register: ISRCTN
• Last refreshed on: 16 September 2019
• Main ID: ISRCTN38736987
• Date of registration: 23/01/2013
• Prospective Registration: No
• Primary sponsor: Barts and The London NHS Trust (UK)
• Public title: A randomised, double-blind, placebo-controlled trial assessing the safety and efficacy of intracoronary NITRITE infusion during Acute Myocardial Infarction
• Scientific title: A randomised, double-blind, placebo-controlled trial assessing the safety and efficacy of intracoronary NITRITE infusion during Acute Myocardial Infarction
• Date of first enrolment: 10/04/2012
• Target sample size: 80
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN38736987
• Study type: Interventional
• Study design: Randomised single centre double-blind placebo-controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Anthony Mathur

Key inclusion & exclusion 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)
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Sodium Chloride, Placebo
10mls Intra-coronary at time of PPCI; Sodium Nitrite, Study IMP
10mls 1.8% intra-coronary during PPCI

The experimental intervention is a bolus of sodium nitrite solution (1.8 micromol in 10 ml (pre-diluted in 0.9% sodium chloride in a syringe) which will be delivered over 30 seconds via intracoronary injection initiated during the re-establishment of antegrade epicardial flow with PPCI.

The control intervention is a bolus of 0.9% sodium chloride solution (prepared with an identical appearance to the sodium nitrite).

Primary Outcome(s)

Creatine Kinase AUC first 48 hours after PPCI

Secondary Outcome(s)

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

Secondary ID(s)

2011-000721-77

12117

NCT01584453

Source(s) of Monetary Support

NIHR (UK) - Doctoral Research Fellowship; Grant Codes: NIHR-DRF-2011-04-080

Ethics review

Status:
Approval date:
Contact:

Committee:- NRES Committee London-West London, 08 November 2011, REC reference: 11/LO/1500

Results

• Results available: Yes
• Date Completed: 10/02/2014