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Acute StrokeNCT05195983

Hemodynamic Changes in Acute Ischaemic Stroke Patients

An observational study of Acute Stroke, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Stroke
How many people
50 participants
Where
No sites listed yet
Study dates
10 Jan 2022to 1 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

Study population: all cases eligible for rtPA will be recruited .

Who may be able to join

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

Who cannot join

  • 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
Show all 21Show fewer
  • 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)

Trial locations and contacts

No sites are listed yet.

Mostafa A. Sedky, resident contact

00201093194172

anwarmoha2006@aun.edu.eg

Anwar M. Ali, professor contact

00201030361010

sedky9752@gmail.vom

About this study

Official title: Hemodynamic Changes in Acute Ischaemic Stroke Patients Receiving Intravenous Thrombolysis.

  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).
Conditions
Acute Stroke
Medical subject headings
Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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.

    Measured: baseline

Secondary outcomes (2)

  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),

    Measured: 24 hours

  2. laboratory outcome

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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2022
  2. Study start10 Jan 2022 (estimated)
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05195983
Sponsor's protocol ID
Acute Ischaemic Stroke
Status last verified
Jan 2022
First submitted
5 Jan 2022
Last updated
19 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Stroke, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mostafa A. Sedky, resident (00201093194172, anwarmoha2006@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical outcomes 1-neurological outcomes (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05195983, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.

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