CClinicalTrials.gg
Status unknownNCT05195983Updated Jan 19, 2022

Hemodynamic Changes in Acute Ischaemic Stroke Patients

An observational study in Acute Stroke, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-01-19.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 80 Years
Sex
All
01

Study summary

  1. To assess Hemodynamic changes in rtPA receiving Acute Ischaemic Stroke patients.
  2. To assess the efficacy of rtPA in treatment of Acute Ischaemic Stroke patients.
  3. To correlate TCD findings (post treatment) with one of standard vascular imaging in AIS (CTA or MRA).
Read the detailed description
  • Stroke is a major healthcare issue worldwide representing the third most common cause of death in the United Kingdom. Approximately 50% of cerebrovascular events were in those aged under 75 years despite previous indications that stroke was more a disease of the elderly population. Stroke can be considered to represent a greater healthcare burden than acute coronary disease resulting from residual disability. A greater understanding of the underlying cause of stroke and subsequent mortality will be required to establish appropriate prevention and treatment strategies.

    1 - Laboratory:

  • The relationship between the neutrophil-to-lymphocyte ratio (NLR) and poor prognostics in acute ischemic stroke (AIS) patients who receive intravenous thrombolysis (IVT) remains controversial. We aimed to determine whether the NLR at admission or post IVT plays a role in AIS patients who received IVT. Fibrin degradation products (FDPs), which can compete with fibrinogen for binding to the platelet membrane and thus interfere with platelet aggregation, are fragments released by the plasmin-mediated degradation of fibrinogen or fibrin. The FDPs level is very sensitive to intravascular thrombus and maybe markedly elevated one the coagulation and fibrinolytic system is activated.

    2- Radiological:

  • Transcranial Doppler ultrasound (TCD) role in detecting acute intracranial artery occlusions is well known. The technique has 94% specificity and 79% sensitivity compared with computerized tomographic angiography (CTA) in acute cerebral ischemia. TCD can provide useful information such as state of collateral flow through the ophthalmic artery and circle of Willis, emboli detection, and real-time bedside monitoring of acute intracranial occlusions. Also, it is useful in selecting patients for bridging therapy after unsuccessful intravenous thrombolysis (IVT).
02

Conditions studied

  • Acute Stroke
03

In context

Stroke

7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.

This study's planned enrollment of 50 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

all cases eligible for rtPA will be recruited .

Inclusion criteria

  • age > 18, both sexes, acute ischemic stroke within 4.5 hours, NIHSS (5-25)

Exclusion criteria

Exclusion Criteria:

  • Significant head trauma or prior stroke in the previous 3 months

    • Symptoms suggest subarachnoid hemorrhage
    • Arterial puncture at a noncompressible site in previous 7 days
    • History of previous intracranial hemorrhage
    • Intracranial neoplasm, AVM, or an aneurysm
    • Recent intracranial or intraspinal surgery
    • Elevated blood pressure (systolic greater than 185 mmHg or diastolic greater than 110 mmHg)
    • Active internal bleeding
    • Acute bleeding diathesis, including but not limited to
    • Platelet count less than 100 000/mm\^3
    • Heparin received within 48 hours resulting in abnormally elevated aPTT above the upper limit of normal
    • Current use of anticoagulant with INR greater than 1.7 or PT greater than 15 seconds
    • Current use of direct thrombin inhibitors or direct factor Xa inhibitors with elevated sensitive laboratory tests (e.g., aPTT, INR, platelet count, ECT, TT, or appropriate factor Xa activity assays)
    • Blood glucose concentration less than 50 mg/dL (2.7 mmol/L)
    • CT demonstrates multilobar infarction (hypodensity greater than a one-third cerebral hemisphere) Relative Exclusion Criteria

Recent experience suggests that under some circumstances, with careful consideration and weighing of risk to benefit, patients may receive fibrinolytic therapy despite 1 or more relative contraindications. Consider the risk to the benefit of intravenous rtPA administration carefully if any of these relative contraindications are present:

  • Only minor or quickly improving stroke symptoms (clearing automatically)
  • Pregnancy
  • Seizure at the onset with postictal residual neurological impairments
  • Major surgery or serious trauma within prior 14 days
  • Recent GI or urinary tract hemorrhage (within previous 21 days)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Clinical outcomes 1-neurological outcomes

    assessed by NIHSS and comprising improvement (reduction of 10 points or final NIHSS ≤3) or deterioration (increase ≥4 points) in the early post-thrombolytic therapy stage

    Time frame: 7 days

  2. 2-functional

    defined by modified Rankin scale (mRS) in the late post-thrombolytic therapy (2-3 months) with good outcome been considered as mRS ≤2 ,with sICH is defined as rtPA-related intracerebral bleeding detected by CT or MRI associated with any worsening of NIHSS or death.

    Time frame: baseline

Secondary outcomes

  1. Radiological outcome

    measured by sonographic features detecting arterial recanalization assessed by different scales \[thrombolysis in brain ischemia (TIBI), and partial or full recanalization\], re-occlusion , and cerebral infarct volume (assessed by a follow up CT or CT Angiography or MRI/MRA),

    Time frame: 24 hours

  2. laboratory outcome

    (Neutrophil To Lymphocyte ratio, fibrin degredation products, ......).

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Arima H, Huang Y, Wang JG, Heeley E, Delcourt C, Parsons M, Li Q, Neal B, Chalmers J, Anderson C; INTERACT1 Investigators. Earlier blood pressure-lowering and greater attenuation of hematoma growth in acute intracerebral hemorrhage: INTERACT pilot phase. Stroke. 2012 Aug;43(8):2236-8. doi: 10.1161/STROKEAHA.112.651422. Epub 2012 Jun 7. PubMed 22678090 ↗
  • Carter AM, Catto AJ, Mansfield MW, Bamford JM, Grant PJ. Predictive variables for mortality after acute ischemic stroke. Stroke. 2007 Jun;38(6):1873-80. doi: 10.1161/STROKEAHA.106.474569. Epub 2007 Apr 19. PubMed 17446429 ↗
  • Gerriets T, Goertler M, Stolz E, Postert T, Sliwka U, Schlachetzki F, Seidel G, Weber S, Kaps M. Feasibility and validity of transcranial duplex sonography in patients with acute stroke. J Neurol Neurosurg Psychiatry. 2002 Jul;73(1):17-20. doi: 10.1136/jnnp.73.1.17. PubMed 12082039 ↗
  • Mazya MV, Ahmed N, Azevedo E, Davalos A, Dorado L, Karlinski M, Lorenzano S, Neumann J, Toni D, Moreira TP; SITS Investigators. Impact of Transcranial Doppler Ultrasound on Logistics and Outcomes in Stroke Thrombolysis: Results From the SITS-ISTR. Stroke. 2018 Jul;49(7):1695-1700. doi: 10.1161/STROKEAHA.118.021485. Epub 2018 May 29. PubMed 29844031 ↗
  • Zhang Z, Pu Y, Mi D, Liu L. Cerebral Hemodynamic Evaluation After Cerebral Recanalization Therapy for Acute Ischemic Stroke. Front Neurol. 2019 Jul 3;10:719. doi: 10.3389/fneur.2019.00719. eCollection 2019. PubMed 31333570 ↗
  • Xu JH, He XW, Li Q, Liu JR, Zhuang MT, Huang FF, Bao GS. Higher Platelet-to-Lymphocyte Ratio Is Associated With Worse Outcomes After Intravenous Thrombolysis in Acute Ischaemic Stroke. Front Neurol. 2019 Nov 13;10:1192. doi: 10.3389/fneur.2019.01192. eCollection 2019. PubMed 31798520 ↗
  • Wang C, Zhang Q, Ji M, Mang J, Xu Z. Prognostic value of the neutrophil-to-lymphocyte ratio in acute ischemic stroke patients treated with intravenous thrombolysis: a systematic review and meta-analysis. BMC Neurol. 2021 May 11;21(1):191. doi: 10.1186/s12883-021-02222-8. PubMed 33975565 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05195983
Lead sponsor
Assiut University
Responsible party
Mustafa Ahmed Sedky Abdallah (resident, Assiut University) — Principal investigator
First posted
Jan 19, 2022
Start date
Jan 10, 2022 (estimated)
Primary completion
Dec 1, 2024 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
Jan 19, 2022

Study contacts

Mostafa A. Sedky, resident
Contact
anwarmoha2006@aun.edu.eg
00201093194172
Anwar M. Ali, professor
Contact
sedky9752@gmail.vom
00201030361010

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion