Feasibility of an ambulance-based stroke trial, and safety of glyceryl trinitrate in ultra-acute stroke: The rapid intervention with glyceryl trinitrate in hypertensive stroke trial (RIGHT, ISRCTN66434824)

Stroke

Volumn 44, Issue 11, 2013, Pages 3120-3128

  Ankolekar, Sandeep ^a,b   Fuller, Michael ^c   Cross, Ian ^c   Renton, Cheryl ^a   Cox, Patrick ^a   Sprigg, Nikola ^a,b   Niroshan Siriwardena, A ^c,d   Bath, Philip M ^a,b  

^a UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^b NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST   (United Kingdom)

^c EAST MIDLANDS AMBULANCE SERVICE NHS TRUST   (United Kingdom)

^d UNIVERSITY OF LINCOLN   (United Kingdom)

Author keywords

Ambulances; Blood pressure; Nitroglycerin; Prehospital; Stroke

Indexed keywords

GLYCERYL TRINITRATE;

AGED; ARTICLE; BLOOD CLOT LYSIS; BRAIN HEMORRHAGE; CEREBROVASCULAR ACCIDENT; CLINICAL ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; DIASTOLIC BLOOD PRESSURE; DRUG SAFETY; FEASIBILITY STUDY; FEMALE; FOLLOW UP; GOOD CLINICAL PRACTICE; HEADACHE; HEMODYNAMICS; HOSPITALIZATION; HUMAN; HYPOTENSION; LENGTH OF STAY; MALE; MORTALITY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RANKIN SCALE; SYSTOLIC BLOOD PRESSURE; TRANSIENT ISCHEMIC ATTACK; ULTRA ACUTE STROKE;

AMBULANCES; BLOOD PRESSURE; NITROGLYCERIN; PREHOSPITAL; STROKE;

AGED; AGED, 80 AND OVER; ALLIED HEALTH PERSONNEL; AMBULANCES; BANDAGES; BLOOD PRESSURE; COHORT STUDIES; EMERGENCY MEDICINE; FEASIBILITY STUDIES; FEMALE; HEMODYNAMICS; HUMANS; HYPERTENSION; MALE; NITROGLYCERIN; PATIENT SAFETY; SINGLE-BLIND METHOD; STROKE; SYSTOLE; TREATMENT OUTCOME;

EID: 84888257544     PISSN: 00392499     EISSN: 15244628     Source Type: Journal    
DOI: 10.1161/STROKEAHA.113.001301     Document Type: Article

References (36)

1. Intravenous Magnesium Efficacy in Stroke (IMAGES) Study Investigators. Magnesium for acute stroke (Intravenous Magnesium Efficacy in Stroke trial): randomised controlled trial. Lancet. 2004;363:439-445.
2. Saver JL, Kidwell C, Eckstein M, Starkman S; FAST-MAG Pilot Trial Investigators. Prehospital neuroprotective therapy for acute stroke: results of the Field Administration of Stroke Therapy-Magnesium (FAST-MAG) pilot trial. Stroke. 2004;35:e106-e108.
3. Sanossian N, Starkman S, Liebeskind DS, Ali LK, Restrepo L, Hamilton S, et al; FAST-MAG Trial Investigators. Simultaneous ring voice-over-Internet phone system enables rapid physician elicitation of explicit informed consent in prehospital stroke treatment trials. Cerebrovasc Dis. 2009;28:539-544.
4. Sanossian N, Starkman S, Eckstein M, Stratton S, Pratt F, Conwit R, et al; FAST-MAG Trial Investigators. Intercontinental elicitation of informed consent for enrollment in stroke research. Cerebrovasc Dis. 2010;30:323-324.
5. Walter S, Kostopoulos P, Haass A, Keller I, Lesmeister M, Schlechtriemen T, et al. Diagnosis and treatment of patients with stroke in a mobile stroke unit versus in hospital: a randomised controlled trial. Lancet Neurol. 2012;11:397-404.
6. Ebinger M, Rozanski M, Waldschmidt C, Weber J, Wendt M, Winter B, et al; STEMO-Consortium. PHANTOM-S: the prehospital acute neurological therapy and optimization of medical care in stroke patients-study. Int J Stroke. 2012;7:348-353.
7. Meairs S, Wahlgren N. Summary of stroke research priorities. The European Commission Stroke. Workshop, Brussels, Belgium; 2005.
8. Bath PM, Pathansali R, Iddenden R, Bath FJ. The effect of transdermal glyceryl trinitrate, a nitric oxide donor, on blood pressure and platelet function in acute stroke. Cerebrovasc Dis. 2001;11:265-272.
9. Rashid P, Weaver C, Leonardi-Bee JA, Fletcher S, Bath FJ, Bath P M W. The effects of transdermal glyceryl trinitrate, a nitric oxide donor on blood pressure, cerebral and cardiac haemodynamics and plasma nitric oxide levels in acute stroke. J Stroke Cerebrovasc Dis. 2003;13:143-151.
10. Willmot M, Ghadami A, Whysall B, Clarke W, Wardlaw J, Bath PM. Transdermal glyceryl trinitrate lowers blood pressure and maintains cerebral blood flow in recent stroke. Hypertension. 2006;47:1209-1215.
11. Leonardi-Bee J, Bath PM, Phillips SJ, Sandercock PA; IST Collaborative Group. Blood pressure and clinical outcomes in the International Stroke Trial. Stroke. 2002;33:1315-1320.
12. Willmot M, Leonardi-Bee J, Bath PM. High blood pressure in acute stroke and subsequent outcome: a systematic review. Hypertension. 2004;43:18-24.
13. Sprigg N, Gray LJ, Bath P M W, Boysen G, De Deyn PP, Friis P, et al. Relationship between outcome and baseline blood pressure and other haemodynamic mreasures in acute ischaemic stroke: data from the taist trial. J Hypertension. 2006;24:1413-1417.
14. Ankolekar S, Sare G, Geeganage C, Fuller M, Stokes L, Sprigg N, et al. Determining the feasibility of ambulance-based randomised controlled trials in patients with ultra-acute stroke: study protocol for the "Rapid Intervention with GTN in Hypertensive Stroke Trial" (RIGHT, ISRCTN66434824). Stroke Res Treat. 2012;2012:385753.
15. Harbison J, Massey A, Barnett L, Hodge D, Ford GA. Rapid ambulance protocol for acute stroke. Lancet. 1999;353:1935.
16. Nor AM, McAllister C, Louw SJ, Dyker AG, Davis M, Jenkinson D, et al. Agreement between ambulance paramedic- and physician-recorded neurological signs with Face Arm Speech Test (FAST) in acute stroke patients. Stroke. 2004;35:1355-1359.
17. Shaw L, Price C, McLure S, Howel D, McColl E, Ford GA. Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study protocol for a pilot randomised controlled trial. Trials. 2011;12:152.
18. Wolff M, Luckow V. In vitro and in vivo-release of nitroglycerin from a new transdermal therapeutic system. Pharmaceut Res. 1985;1:23-29.
19. Gray LJ, Sprigg N, Rashid PA, Willmot M, Bath P M W. Effect of nitric oxide donors on blood pressure and pulse pressure in acute and sub-actue stroke. J Stroke Cerebrovasc Dis. 2006;15:245-249.
20. Bath PM, Lindenstrom E, Boysen G, De Deyn P, Friis P, Leys D, et al. Tinzaparin in acute ischaemic stroke (TAIST): a randomised aspirin-controlled trial. Lancet. 2001;358:702-710.
21. The ENOS Trial Investigators. Glyceryl trinitrate vs. control, and continuing vs. stopping temporarily prior antihypertensive therapy, in acute stroke: rationale and design of the Efficacy of Nitric Oxide in Stroke (ENOS) trial (isrctn99414122). Int J Stroke. 2006;1:245-249.
22. Lees KR, Bath P M W, Schellinger PD, Kerr DM, Fulton R, Hacke W, et al. Contemporary outcome measures in acute stroke research: choice of primary outcome measure. Stroke. 2012;43:1163-1170.
23. Wade DT. Measurement in Neurological Rehabilitation. Oxford: Oxford University Press; 1992.
24. Schellinger PD, Bath P M W, Lees K, Bornstein NM, Uriel E, Eisert W, et al. Assessment of addtional endpoints relevant to the benefit of patients after stroke-what, when, where, in whom. Int J Stroke. 2012;7:227-230.
25. Zung WW. A Self-Rating Depression Scale. Arch Gen Psychiatry. 1965;12:63-70.
26. Euroqol Group. Euroqol-a new facility for the measurement of healthrelated quality of life. The euroqol group. Health Policy. 1990;16:199-208.
27. The Optimising Analysis of Stroke Trials (OAST) Collaboration. Can we improve the statistical analysis of stroke trials? Statistical re-analysis of functional outcomes in stroke trials. Stroke. 2007;38:1911-1915.
28. Bath PM, Lees KR, Schellinger PD, Altman H, Bland M, Hogg C, et al. Statistical analysis of the primary outcome in acute stroke trials. Stroke. 2012;43:1171-1178.
29. Optimising the Analysis of Stroke Trials Collaboration With the Writing Committee, Bath P, Hogg C, Tracy M, Pocock S. Calculation of numbers-needed-to-treat in parallel group trials assessing ordinal outcomes: case examples from acute stroke and stroke prevention. Int J Stroke. 2011;6:472-479.
30. Potter JF, Robinson TG, Ford GA, Mistri A, James M, Chernova J, et al. Controlling hypertension and hypotension immediately post-stroke (CHHIPS): a randomised, placebo-controlled, double-blind pilot trial. Lancet Neurol. 2009;8:48-56.
31. Sandset EC, Bath PM, Boysen G, Jatuzis D, Korv J, Luders S, et al. The angiotensin-receptor blocker candesartan for treatment of acute stroke (SCAST): a randomised, placebo-controlled double-blind trial. Lancet. 2011;377:741-750.
32. Wahlgren NG, MacMahon DG, De Keyser J, Indredavik B, Ryman T, INWEST Study Group. Intravenous Nimodipine West European Stroke Trial (INWEST) of nimodipine in the treatment of acute ischaemic stroke. Cerebrovasc Dis. 1994;4:204-210.
33. Lees KR, Bluhmki E, Von Kummer R, Brott TG, Toni D, Grotta JC, et al; ECASS, ATLANTIS, NINDS and EPITHET rt-PA Study Group. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet. 2010;375:1695-1703.
34. Geeganage CM, Bath PM. Relationship between therapeutic changes in blood pressure and outcomes in acute stroke: a metaregression. Hypertension. 2009;54:775-781.
35. The Optimising Analysis of Stroke Trials (OAST) Collaboration. Should stroke trials adjust functional outcome for baseline prognostic factors? Stroke. 2009;40:888-894.
36. Morikawa E, Rosenblatt S, Moskowitz MA. L-arginine dilates rat pial arterioles by nitric oxide-dependent mechanisms and increases blood flow during focal cerebral ischaemia. Br J Pharmacol. 1992;107:905-907.