Acute stroke treatment in the ambulance with a nitroglycerin patch
- Conditions
- Acute ischaemic stroke and intracerebral haemorrhageNervous System Diseases
- Registration Number
- ISRCTN99503308
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31242931 protocol (added 28/06/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36058230/ (added 05/09/2022) 2019 Abstract results in https://doi.org/10.1177/2396987319848124 (added 13/02/2024) 2021 Abstract results in https://doi.org/10.1177/23969873211044666 (added 13/02/2024) 2022 Abstract results in https://doi.org/10.1177/23969873221087559 (added 13/02/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 325
1. Age 18 years or older
2. Probable diagnosis of acute stroke, as assessed by the paramedic in the prehospital setting
3. Score of 2 or 3 on the Face Arm Speech Test (FAST)
4. Systolic blood pressure = 140 mm Hg
5. Possibility to start the trial treatment within 3 hours of symptom onset
6. Intention to transport the patient to one of the participating hospitals
7. Written informed consent (deferred)
1. Considerable pre-stroke dependency in activities of daily living, defined as staying in a chronic nursing home or rehabilitation centre
2. Known pregnancy or lactation
3. Indication for acute treatment with nitroglycerin or known use of nitroglycerin in the previous 12 hours
4. Indication for acute reduction of blood pressure
5. Known hypersensitivity to GTN, nitrates in general, or the adhesives used in the patch
6. Glasgow Coma Scale < 8
7. Known with any of the following heart disorders: myocardial insufficiency due to obstruction; aortic or mitral valve stenosis; constrictive pericarditis; hypertrophic obstructive cardiomyopathy; cardiac tamponade
8. Known marked anaemia, defined as haemoglobin < 5 mmol/L
9. Known closed angle glaucoma
10. Known concomitant use of phosphodiesterase type-5 inhibitors, (e.g. sildenafil, tadalafil, vardenafil)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional outcome is assessed using the modified Rankin Scale (mRS) at 90 days.
- Secondary Outcome Measures
Name Time Method 1. At hospital admission: <br>1.1. Vital signs (blood pressure and heart rate)<br>1.2. Collateral circulation assessed with CT-angiography<br>2. At 24 hours: <br>2.1. Treatment with intravenous thrombolysis and/or endovascular treatment<br>2.2. Vital signs (blood pressure and heart rate)<br>2.3. Neurological deficit assessed using the National Institutes of Health Stroke Scale (NIHSS)<br>3. At 90 days, assessed during a blinded telephone interview: <br>3.1. Death <br>3.2. Dichotomised mRS (0-1 vs. 2-6; 0-2 vs. 3-6; 0-3 vs. 4-6)<br>3.3. Disability assessed with the score on the Barthel Index<br>3.4. Quality of life assessed with the EuroQol-5D-5L<br>3.5. Home time and patient location over the first 90 days