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Angiogenic Markers in Cerebrovascular Disease (ANFIS) (ANFIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240119
Recruitment Status : Enrolling by invitation
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Nestor R. Gonzalez, MD, MSCR., Cedars-Sinai Medical Center

Tracking Information
First Submitted Date January 21, 2020
First Posted Date January 27, 2020
Last Update Posted Date January 27, 2020
Study Start Date July 2012
Estimated Primary Completion Date July 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 21, 2020)
  • Recurring cerebrovascular events [ Time Frame: 2 years ]
  • Plasma levels of angiogenic factors [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Angiogenic Markers in Cerebrovascular Disease (ANFIS)
Official Title Angiogenic Factors in Stroke (ANFIS)
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.

Detailed Description

Intracranial atherosclerosis (ICAS) is the most common cause of stroke worldwide. It accounts for at least 10% of all strokes in the United States and as much as 67% in countries with predominantly Asian, Hispanic, and Black populations. ICAS 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. Recent randomized controlled clinical trials have shown that angioplasty with stenting and bypass surgery fail to improve outcomes in patients with ICAS.

Overall treatment and prevention of stroke due to ICAS has been unsuccessful. The results of two recent clinical trials exploring interventions for the management of cerebrovascular occlusive disease—bypass surgery (Carotid Occlusion Surgery Study [COSS]) and angioplasty and stenting (SAMMPRIS)—have shown modest improvement in the efficacy of intensive medical treatment. However, both trials were terminated early given the elevated rate of complications, stroke, and death in the interventional arms. In the medical arms of COSS and SAMMPRIS, the rates of stroke and death at two years were 21% and 15%, respectively. 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. Patients with prior stroke had an even higher rate of stroke, 35%.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood
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.
Condition
  • Stroke
  • Transient Ischemic Attack
  • Atherosclerosis
  • Intracranial Arterial Stenosis
  • Moyamoya
Intervention Other: According to current clinical care standards
Enrolled subjects may be treated with medical management or surgically using indirect revascularization surgery.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: January 21, 2020)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2030
Estimated Primary Completion Date July 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 70% to 99% ICAS of a major intracranial artery diagnosed by angio, TCD, MRA, or CTA.

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04240119
Other Study ID Numbers Pro00046030
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Data may be shared in the future, but currently no specific plans exist.
Responsible Party Nestor R. Gonzalez, MD, MSCR., Cedars-Sinai Medical Center
Study Sponsor Cedars-Sinai Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Nestor R Gonzalez, MD., MSCR Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date January 2020