Cerebral Small Vessel Diseases Clinical Trial
— ETLASOfficial title:
The Effect of Tadalafil on Cerebral Large Arteries in Stroke Patients
Verified date | August 2017 |
Source | Herlev Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In a double blind placebo-controlled cross-over study the effect of tadalafil on blood flow velocity in the large arteries of the brain, cortical brain oxygenation, peripheral endothelial function, and endothelial biomarkers will be tested in patients with lacunar stroke caused by cerebral small vessel disease.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 4, 2017 |
Est. primary completion date | August 4, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: 1. Radiological evidence of cerebral small vessel disease defined as: MRI evidence of lacunar infarct(s) (= 1.5 cm maximum diameter) and/or confluent deep white matter leukoaraiosis (= grade 2 on Fazekas scale). 2. Clinical evidence of cerebral small vessel disease can be: 1. lacunar stroke syndrome with symptoms lasting >24 hours occurring at least 5 months previously; OR 2. transient ischemic attack (TIA) lasting < 24 hours with limb weakness, hemi-sensory loss or dysarthria at least 5 months previously AND with MR DWI performed acutely showing lacunar infarction, OR if MRI is not performed within ten days of TIA, a lacunar infarction in an anatomically appropriate position is demonstrated on a subsequent MRI. 3. Age = 50 years. 4. Imaging of the carotid arteries with Doppler ultrasound, CT angiography, or MR angiography in the previous 12 months demonstrating < 70% stenosis in both internal carotid arteries. Exclusion Criteria: 1. Known diagnosis of dementia 2. Pregnancy or nursing 3. Cortical infarction (>1.5 cm maximum diameter) 4. Systolic BP < 90 and/or diastolic BP < 50 5. eGFR < 30 ml/min/1,73m2 6. Severe hepatic impairment 7. History of Lactose intolerance 8. Concomitant use of PDE5 inhibitors e.g. sildenafil, tadalafil, vardenafil 9. Patients receiving nicorandil and nitrates e.g. isosorbide mononitrate, isosorbide dinitrate, glyceryl trinitrate 10. Body weight > 130kg 11. Uncontrolled cardiac failure 12. Persistent or paroxysmal atrial fibrillation 13. History of "sick sinus syndrome" or other supraventricular cardiac conduction conditions such as sinoatrial or atrioventricular block 14. Uncontrolled COPD 15. Stroke or TIA within the last 5 months. 16. MRI not tolerated or contraindicated: MRI exclusion criteria: Participant has a cardiac pacemaker; recent surgery; vascular clips; metal implants or joint replacements that are not compatible with MRI; have had metal fragments in their eyes; has ever worked on a lathe; has shrapnel from a war injury; possibility of pregnancy 17. Known monogenic causes of stroke i.e. CADASIL 18. The patient does not wish to know important results from MRI 19. Unable to provide informed consent 20. Not possible to localise a. cerebri media bilaterally on inclusion day with Transcranial Doppler |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Neurology, Herlev-Gentofte Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Christina Kruuse |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in Blood flow velocity change in middel cerebral artery (MCA) between placebo and tadalafil | Change in Blood flow velocity in middel cerebral artery (MCA) will be measured with transcranial doppler (TCD) before and up to three hours after intake of tadalafil/placebo. | Measurement before and up to three hours after intake of tadalafil/placebo. | |
Primary | Difference in cortical brain oxygenation between placebo and tadalafil | Cortical brain oxygenation will be measured with near-infrared spectroscopy (NIRS) before and up to three hours after intake of tadalafil/placebo. | Measurement before and up to three hours after intake of tadalafil/placebo. | |
Secondary | Changes in endothelial response | Measurement of endothelial response by EndoPAT2000 before and three hours after intake of tadalafil/placebo. | Measurement before and three hours after intake of tadalafil/placebo. | |
Secondary | Changes in endothelial biomarkers in blood | Blood samples to measure changes in endothelial biomarkers (eg. e-selectin, VCAM, ICAM, endothelin, ADMA, miRNA) before and 3,5-4 hours after intake of tadalafil/placebo. | Blood samples before and 3,5-4 hours after intake of tadalafil/placebo. |
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