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临床试验/NCT03153683
NCT03153683
招募中
不适用

Brain, Blood And Clot or Tissue Registry And Collaboration (BACTRAC)

Justin Fraser1 个研究点 分布在 1 个国家目标入组 1,000 人2017年5月11日

概览

阶段
不适用
干预措施
Registry
疾病 / 适应症
Acute Ischemic Stroke
发起方
Justin Fraser
入组人数
1000
试验地点
1
主要终点
Evaluate pH of blood as a marker of acid/base balance in distal blood and proximal blood, and correlate to interval of time between Last Known Normal and vessel recanalization.
状态
招募中
最后更新
上个月

概览

简要总结

This is a prospective open enrollment biorepository to collect and evaluate blood and tissue collected during cerebrovascular procedures, which will then be used for the purposes of identifying biological markers, inflammatory cell infiltrates, and biological states in stroke and other cerebrovascular diseases in the human condition.

The study population will include up to 1000 subjects with cerebrovascular disease or suspected cerebrovascular disease. Male and female participants 18 years of age and older will be enrolled.

This protocol covers the procurement of biological samples from patients undergoing any cerebrovascular surgery and/or neurointerventional clinical procedure at University of Kentucky. Control participants will include patients undergoing non-emergent, elective diagnostic cerebral angiography as well as patients undergoing emergent angiogram cases.

This study represents the first time that tissue, clot and blood will be evaluated for the markers, proteins, and cytokines in human subjects undergoing cerebrovascular procedures.

By starting with the human condition, the investigators aim to minimize this loss in translation. Overall, this study will have a great impact on our knowledge of stroke pathology. In essence, this could fundamentally change not only how the investigators develop treatment strategies for the stroke patient population but allow us to individualize the treatment dependent on time after stroke, age, sex, and co-morbidities. Molecular techniques that are impractical when delivered systemically could be delivered locally to impede the early inflammation.

This research aims to advance understanding of cerebrovascular disease and to support the development of improved therapies.

详细描述

This is a prospective open enrollment biorepository to collect and evaluate blood and tissue collected during cerebrovascular procedures, which will then be used for the purposes of identifying biological markers, inflammatory cell infiltrates, and biological states in stroke and other cerebrovascular diseases in the human condition. This research aims to advance understanding of cerebrovascular disease and to support the development of improved therapies. The study population will include up to 1000 subjects with cerebrovascular disease or suspected cerebrovascular disease. Male and female participants 18 years of age and older will be enrolled. Participants will be recruited from patients evaluated at University of Kentucky Chandler Hospital for cerebrovascular procedures . Participants with impaired capacity may be included as the pathology to be studied may impair their capacity. The primary endpoints of the study will be evaluation of specific proteins and leukocyte populations in the human stroke clot, tissues and blood. The following describes all study procedures and evaluations that are to be done as part of the study. Baseline: * Verify inclusion/exclusion criteria * Obtain consent from the patient or Legally Authorized Representative (LAR). * Medical history taken from medical record, participant and family to determine eligibility based on inclusion/exclusion criteria (Standard of Care) * Medication history (Standard of Care) * Baseline physical examination to include vital signs (Standard of Care) * Premorbid Modified Ranking Score (mRS) * NIH Stroke Scale (Standard of Care) * BMI (Standard of Care) * Cerebrovascular procedure (Standard of Care) * Study Specimen Collection Data points recorded may include: * concomitant medications * the vessel location of the thrombus or disease * the time from Last Known Normal to vessel recanalization * the TICI score * the CTA collateral score at presentation * the baseline serum bicarbonate * the baseline O2 saturation * Medical history /co-morbid conditions Study Specimen Collection This protocol covers the procurement of tissue samples, blood samples, and other biological samples from patients undergoing any cerebrovascular surgery and/or clinical procedure. Any tissue or biological sample that is procured as part of a normal cerebrovascular procedures and which would otherwise be discarded can be collected under this protocol. Examples of these tissue samples include: * Blood vessels (arterial or venous) * Brain tissue * Thrombus tissue * AVM nidus from resection * AVF nidus from resection * Aneurysms if resected * Carotid stenosis plaques from CEA Peripheral blood samples may also be collected from patients. These are the only biospecimens that will be procured specifically for this research and that are not collected as part of normal cardiac care. These samples will consist of 5 to 10 cc of peripheral blood and may be collected: * Prior to procedure * Immediately after procedure * At different time intervals after the procedure during the hospital stay. These samples will not exceed the frequency and volume limits detailed in the IRB regulations * At the outpatient follow-up after procedure * Annually at an office-visit * Upon readmission if hospitalized

注册库
clinicaltrials.gov
开始日期
2017年5月11日
结束日期
2029年12月28日
最后更新
上个月
研究类型
Observational
性别
All

研究者

发起方
Justin Fraser
责任方
Sponsor Investigator
主要研究者

Justin Fraser

Professor of Cerebrovascular, Endovascular, & Skull Base Surgery; Director, Cerebrovascular Surgery; Depts of Neurological Surgery, Neurology, Radiology, and Anatomy & Neurobiology; Center for Advanced Translational Stroke Science; Univ of KY

University of Kentucky

入排标准

入选标准

  • All patients, Male or female, aged 18 years or older, undergoing cerebrovascular surgery/procedure at the University of Kentucky.

排除标准

  • 1\. Pregnant or breastfeeding females

研究组 & 干预措施

Cerebrovascular procedure patients

This is a registry. No above standard of care interventions will take place. Participants must be undergoing a clinically routine cerebrovascular procedure.

干预措施: Registry

结局指标

主要结局

Evaluate pH of blood as a marker of acid/base balance in distal blood and proximal blood, and correlate to interval of time between Last Known Normal and vessel recanalization.

时间窗: Assessed over the course of the study, an estimated 3 years.

A small amount of blood (from the two specimens) will be sent for blood gas analysis to evaluate the pH, pO2, pCO2, pHCO3 potassium, sodium, and calcium concentrations.

研究点 (1)

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