Hemodynamic Changes in Acute Ischaemic Stroke Patients

NCT05195983 | Unknown

• 1 other identifier: Acute Ischaemic Stroke
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To assess Hemodynamic changes in rtPA receiving Acute Ischaemic Stroke patients.
2. 2.To assess the efficacy of rtPA in treatment of Acute Ischaemic Stroke patients.
3. 3.To correlate TCD findings (post treatment) with one of standard vascular imaging in AIS (CTA or MRA).

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (2)

• 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

  7 days

• 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.

  baseline

Secondary Outcomes (2)

• Radiological outcome

  24 hours

• laboratory outcome

  baseline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all cases eligible for rtPA will be recruited .

You may qualify if:

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

You may not qualify if:

• 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)
• 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:

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 22678090 BACKGROUND

• 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.

  PMID: 17446429 BACKGROUND

• 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.

  PMID: 12082039 BACKGROUND

• 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.

  PMID: 29844031 BACKGROUND

• 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.

  PMID: 31333570 BACKGROUND

• 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.

  PMID: 31798520 BACKGROUND

• 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.

  PMID: 33975565 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Mostafa A. Sedky, resident

CONTACT

00201093194172; anwarmoha2006@aun.edu.eg

Anwar M. Ali, professor

CONTACT

00201030361010; sedky9752@gmail.vom

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 19, 2022
• Study Start: January 10, 2022
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: January 19, 2022

Record last verified: 2022-01