Angiogenic Markers in Cerebrovascular Disease (ANFIS)

NCT04240119 | Enrolling By Invitation

• 1 other identifier: Pro00046030
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke; Transient Ischemic Attack; Atherosclerosis; Intracranial Arterial Stenosis; Moyamoya

Outcome Measures

Primary Outcomes (2)

• Recurring cerebrovascular events

  2 years

• Plasma levels of angiogenic factors

  2 years

Interventions

According to current clinical care standards OTHER

Enrolled subjects may be treated with medical management or surgically using indirect revascularization surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited during hospitalizations or neurological and/or neurosurgical office visits at Cedars Sinai Medical Center.

You may qualify if:

• % to 99% ICAS of a major intracranial artery diagnosed by angio, TCD, MRA, or CTA.

You may not qualify if:

• Intracranial tumor or vascular malformation.
• Any hemorrhagic infarct within 14 days before enrollment or any other intracranial hemorrhage (subarachnoid, subdural, or epidural) within 30 days.
• Intracranial arterial stenosis related to arterial dissection or any known infectious or vasculitic disease.
• Presence of any unequivocal cardiac sources of embolism.
• Major surgery within previous 30 days before enrollment or planned in the next 180 days after enrollment,
• Severe neurologic deficit that renders the patient incapable of living independently.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Atherosclerosis; Moyamoya Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Carotid Artery Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases

Study Officials

• Nestor R Gonzalez, MD., MSCR

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurosurgery

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: July 1, 2012
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 8, 2023

Record last verified: 2023-02