NCT04240119Enrolling by invitation
Angiogenic Markers in Cerebrovascular Disease (ANFIS)
Angiogenic Factors in Stroke (ANFIS)
Source: ClinicalTrials.gov · Last updated 8 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Intracranial atherosclerosis (ICAS) is the most common cause of stroke worldwide. It carries a worse prognosis than other stroke etiologies, with an annual rate of recurrent stroke and death of 15% despite intensive medical management, and as high as 35% in certain populations. Overall, treatment and prevention of stroke due to ICAS has been unsuccessful. While two recent clinical trials have shown modest improvement in the efficacy of intensive medical treatment, these trials were terminated early given the elevated rate of complications, stroke, and death in the interventional arms. In fact, intensive medical management appears to reduce the risk of embolism; however, medical management alone does not address the progression of intracranial arterial stenosis or the pathophysiologic components of hypoperfusion and poor collateral circulation. Levels and types of various angiogenic factors in the blood and tissues have been proposed to be predictive of patient outcome after ischemic stroke and treatment for stroke. This study therefore pursues a new paradigm to investigate responses to ICAS treatment from the perspective of cerebral collateral vessel generation and the role of angiogenic factors. Specifically, pro- and anti-angiogenic factors in patients with ICAS are evaluated at baseline and longitudinally in response to both medical and surgical treatment. For this we have developed methodologies for the isolation and measurement of these growth factors in plasma of patients with ICAS. These methodologies will enable us to obtain a detailed understanding of the variation and dynamic properties of local and circulating angiogenic factors over time in response to medical and surgical treatment, and their association to outcome phenotypes. This analysis is complemented by studies of angiographic development of neovascularization. If successful, this study will help to better understand the role of angiogenesis in ICAS and create a foundation from which to explore therapeutic treatments for ICAS which harness the natural processes of angiogenesis.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 21 Jan 2020
- Start date
- Jul 2012
- Primary completion date
- Jul 2030
- Lead sponsor
- Cedars-Sinai Medical Center
- Diseases
- Stroke
- NCT number
- NCT04240119
What you commit to
- Study type: Observational
- Planned participants: 300
- From Jul 2012 to the primary completion date, Jul 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any hemorrhagic infarct within 14 days before enrollment or any other intracranial hemorrhage (subarachnoid, subdural, or epidural) within 30 days.
- Major surgery within previous 30 days before enrollment or planned in the next 180 days after enrollment,
Other illness
- Intracranial arterial stenosis related to arterial dissection or any known infectious or vasculitic disease.
- Presence of any unequivocal cardiac sources of embolism.
Other
- Intracranial tumor or vascular malformation.
- Severe neurologic deficit that renders the patient incapable of living independently.
Who the study is looking for
- 70% to 99% ICAS of a major intracranial artery diagnosed by angio, TCD, MRA, or CTA.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.