Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03297827 |
| Other study ID # |
17-315 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2019 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
November 2020 |
| Source |
University of New Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Various molecules (cytokines: interleukins, interferons and neural proteins) found in human
and animal blood are reported to be elevated in acute stroke (Ischemic and hemorrhagic).
Cytokines can be pro-inflammatory or anti-inflammatory. There are studies confirming level
changes in serum of humans in the setting of several rheumatologic and cardiovascular
diseases. As new molecular markers (cytokines and neural tissue markers) are established in
scientific literature, stroke scientists are interested to evaluate the role of these in the
pathophysiology of stroke. Investigators intend to study the role of these molecules in the
development of stroke.
Acute stroke treatment has advanced considerably in the last 10 years with the establishment
of comprehensive stroke centers and approval of neuro-interventional techniques. However, the
molecular advancement in stroke pathogenesis has yet to reach a milestone in the world of
stroke treatment. In our opinion, creating a database of acute stroke patients containing all
pertinent medical demographics and clinical information along with the laboratory data,
molecular levels of pertinent cytokines/neural factors from consenting patients, will help us
define and delineate the most relevant molecules that are altered in acute stroke patients
and can help us further improve us understanding of the role of these in acute stroke and
thereby hopefully help in the improvement of our understanding and management of stroke.
Moreover, analyzing the cytokines in stroke and ICH patients would help understand their role
in the acute phase, which may become potential therapeutic adjuncts for tPA and endovascular
thrombectomy.
Description:
Stroke is the fifth cause of all-cause mortality in US http://www.cdc.gov/stroke/facts.htm .
Early identification and treatment not only prevent mortality but also morbidity. Recent
advancement in the imaging and diagnostic technique and novel therapeutic modalities has
dramatically helped to downgrade stroke from the list of top mortality index in the last 3
years. However, studies determining factors which help predict stroke outcome are still
underway and much work needs to be done in this direction. Many factors currently are used to
predict stroke outcome with varying results, for e.g. NIHSS is a good predictor of stroke
outcome at 3 months; however, we need better predictors, outcome scales or outcome measures
which are easy, reliable and has better specificity and sensitivity.
There is also some correlation of clinical and biochemical predictors in subarachnoid,
cerebral venous thrombosis including Hunt and Hess, SAH score, WFNS-SAH grading among others
with variable predictive quality. (Rosen et al; Neurocritical Care; April 2005, Volume 2,
Issue 2, pp 110- 118: Subarachnoid hemorrhage grading scales).
During the acute phase of focal cerebral ischemia, there is an elevation of thrombin activity
and a decline in fibrinolytic activity. Moreover, the role of pro-inflammatory cytokines has
been proven in the last few decades, as markers of inflammation have been closely studied in
mice models; there are indications that elevated levels correlate with the extent of ischemic
injury. Various interleukins were found to be elevated in most if not all patients with acute
ischemic stroke. Correlation of hemostatic (procoagulant and fibrinolytic markers) with
inflammatory markers is under discussion, with no confirmed common marker identified as of
yet.
As new cytokines and tissue markers are established in scientific literature, stroke
scientists are interested in evaluating the role of these markers in the pathophysiology of
stroke. The role of glial cell markers has been of remarkable interest. Recently, an
astrocyte marker S100B has shown association with infarct size, neurological outcome, and
prognosis. Moreover, analyzing the cytokines in stroke and ICH patients would help understand
their role in the acute phase, which may become potential therapeutic adjuncts for tpa and
endovascular thrombectomy. In summary, inflammation in acute stroke is an area of interest in
the recent years, with the theoretical benefit of aborting the inflammatory chain during
acute stroke might be useful in limiting stroke-related brain damage or hemorrhagic
transformation in acute stroke.
