Hypertension, Unruptured Intracranial Aneurysm
Conditions
Keywords
Unruptured Intracranial Aneurysm, Hypertension
Brief summary
The goal of this randomized controlled trial is to evaluate the benefits and safety of controlled hypotension in Chinese patients with unruptured intracranial aneurysms(UIA). The main questions it aims to answer are: * To provide high-level evidence of the benefits and safety of controlled hypotension in patients with UIA. * To provide evidence-based medical evidence for blood pressure control of patients with UIA in neurosurgery, and promote the progress of accurate individual management of patients. In this study, the main intervention is enhanced blood pressure lowering in patients with UIA. All Patients will be randomly assigned to either the standard blood pressure lowering (SBPL) group or the enhanced blood pressure lowering (EBPL) group.
Interventions
OTHERblood pressure lowering
For EBPL group, patients are required to keep blood pressure at 100-120 mmHg. For SBPL group, patients are required to keep blood pressure \<140 mmHg.
Sponsors
Beijing Tiantan Hospital
RenJi Hospital
Guangzhou Red Cross Hospital
Jiangnan University Medical Center
Beijing Friendship Hospital
Beijing Chao Yang Hospital
Beijing Anzhen Hospital
First Affiliated Hospital of Fujian Medical University
Binzhou People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75. 2. Chinese ethnicity. 3. Unruptured saccular intracranial aneurysm (UIA) identified by computational tomography angiography, magnetic resonance angiography or digital subtraction angiography. 1. Maximal size of UIA at largest dimension \< 7 mm 2. The morphology of UIA is regular (no bleb(s) or secondary aneurysm(s) protruding from the UIA fundus or bi-/ multi-lobular UIA fundus) 3. UIA receiving conservative treatment 4. History of primary hypertension (as diagnosed per standard of care) 5. Systolic blood pressure (SBP) on 2 consecutive visits: SBP: 130-180 mmHg on 0 or 1 antihypertensive medication. SBP: 130-170 mmHg on up to 2 antihypertensive medications. SBP: 130-160 mmHg on up to 3 antihypertensive medications. SBP: 130-150 mmHg on up to 4 antihypertensive medications 6. Good medication adherence (Morisky Medication Adherence Scale ≥6) 7. Obtain informed consent from patient or legal representative
Exclusion criteria
1. Patients with neurological symptom related to UIA, such as sentinel headache, oculomotor paralysis and so on. 2. Patients with additional active intracranial disease including vasculopathy, arteriovenous malformation/fistula, cancer, traumatic brain injury etc. 3. Patients with fusiform, dissecting, blister, traumatic, mycotic/ bacterial, myxomatous, and tumor-associated UIAs are excluded. 4. Patients with history of polycystic kidney disease, rheumatic disease or autoimmune disease. 5. Patients with family history of intracranial aneurysm (defined when two direct relatives of patients within three generations have intracranial aneurysms or aneurysmal subarachnoid hemorrhage). 6. Patients with known secondary cause of hypertension. 7. Patients with myocardial infarction, ischemic stroke, symptomatic heart failure during the past 3 months. 8. Patients with a medical condition likely to limit survival to less than 2 years. 9. Patients during pregnancy and perinatal period. 10. Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease. 11. Inability or unwillingness of patient or legal representative to give written informed consent. 12. Participation in a concurrent interventional medical investigation or clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UIA instability | Within 24 months after randomization | The primary outcome is UIA instability (rupture, growth on radiological examination, or occurrence of aneurysm-related symptoms \[sentinel headache and oculomotor paralysis\]). |
| safety endpoint | Within 24 months after randomization | The safety endpoint is any ischemic cerebral or cardiac events. This includes one or more of the following: new or more frequent transient ischemic attack, new clinical or radiological ischemic stroke, angina, new myocardial infarction, or reperfusion therapy for myocardial infarction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UIA rupture events | Within 24 months after randomization | UIA rupture events within 24 months after randomization |
| UIA growth events | Within 24 months after randomization | UIA growth events within 24 months after randomization |
| Change in average Wall Enhancement Index | At baseline and 24th month after randomization | Change in average Wall Enhancement Index (WEI) at baseline and 24th month |
Countries
China
Outcome results
None listed