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21 March 2013
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| [ Print-friendly version ] |
| A randomised, double-blind, placebo-controlled trial assessing the safety and efficacy of intracoronary NITRITE infusion during Acute Myocardial Infarction |
| ISRCTN | ISRCTN38736987 |
| DOI | 10.1186/ISRCTN38736987 |
| ClinicalTrials.gov identifier | |
| EudraCT number | 2011-000721-77 |
| Public title | A randomised, double-blind, placebo-controlled trial assessing the safety and efficacy of intracoronary NITRITE infusion during Acute Myocardial Infarction |
| Scientific title | |
| Acronym | NITRITE-AMI |
| Serial number at source | 12117 |
| Study hypothesis |
Despite advances in the treatment of heart attacks such as reopening of the blocked artery (primary angioplasty), the complications and death rates from failure of the heart to pump adequately remain high. The size of the heart attack is the major determinant of these adverse outcomes. Whilst reopening the artery allows blood to flow to the area of the heart starved of oxygen, this process also causes damage itself (“reperfusion injury”) and increases the size of the heart attack.
It has been shown that nitrite protects against reperfusion injury in models of heart attack. We will therefore perform a trial to investigate whether during a heart attack, an infusion of nitrite into the damaged artery protects against reperfusion injury and reduces heart attack size. More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12117 |
| Lay summary | Not provided at time of registration |
| Ethics approval | Committee:- NRES Committee London-West London, 08 November 2011, REC reference: 11/LO/1500 |
| Study design | Randomised single centre double-blind placebo-controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Atherothrombosis |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 10/04/2012 |
| Anticipated end date | 10/02/2014 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | UK Sample Size: 80 |
| Interventions |
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 measure(s) | Creatine Kinase AUC first 48 hours after PPCI |
| Secondary outcome measure(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 |
| Sources of funding | NIHR (UK) - Doctoral Research Fellowship; Grant Codes: NIHR-DRF-2011-04-080 |
| Trial website | |
| Publications | |
| Contact name | Prof Anthony Mathur |
| Address |
London Chest Hospital
Victoria Park Site Bonner Road |
| City/town | London |
| Zip/Postcode | E2 9JX |
| Country | United Kingdom |
| a.mathur@qmul.ac.uk | |
| Sponsor | Barts and The London NHS Trust (UK) |
| Address |
Joint Research Office
24-26 Walden Street |
| City/town | London |
| Zip/Postcode | E1 2AN |
| Country | United Kingdom |
| Sponsor website: | http://www.bartsandthelondon.nhs.uk/ |
| Date applied | 18/01/2013 |
| Last edited | 23/01/2013 |
| Date ISRCTN assigned | 23/01/2013 |
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