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NCT Number: NCT03367286

Comparison Influence to Prognosis of CTP and MRP in AIS Patients

Acute ischemia stroke (AIS) is the leading cause of death in China. Thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) has been proven to reduce disability in AIS patients within 4.5 hours after symptom onset. However, only 2% of AIS patients received thrombolytic therapy in China.

Perfusion imaging is demonstrated to increase the rate of thrombolytic therapy by identifying the ischemic infarct core (the brain tissue that is irreversibly injured) and the ischemia penumbra (the brain tissue surrounding the ischemia infarct core that is hypoperfused but still viable) for those patients with extending therapeutic window (beyond the current 4.5 hours after symptom onset), as well as minor stroke or those with atypical symptoms.

Three prospective clinical trials, DEFUSE, DEFUSE-2 and EPITHET, has confirmed that mismatch between perfusion weighted-imaging (PWI) and diffusion weighted-imaging (DWI) correspond to the ischemic penumbra whereas DWI provides information of the ischemia infarct core and major reperfusion relate to good clinical outcome in extending therapeutic window AIS patients with DWI-PWI mismatch.

Computed tomography perfusion (CTP) may be a potential alternative technology for recognition of reversibly damaged brain tissue in AIS patients, with the prominent advantage of fast scan. Recent studies also demonstrated that CTP could select eligible candidates for reperfusion therapy. More recently, with data of EXTEND-IA, reperfusion therapy in AIS patients with CTP mismatch (using a CT time to maximum >6 s as ischemic hypoperfusion volume and a CT relative cerebral blood flow <30% of that in normal tissue as ischemic core volume) were related to good clinical outcome.

However, plenty of studies demonstrated CT cerebral blood volume did not always predict ischemic infarct core in AIS patients. A recent study also confirmed the poor contrast: noise ratios of CT cerebral blood volume and CT cerebral blood flow result in large measurement error, compared with those of diffusion weighted imaging (DWI), making it problematic to substitute DWI in selecting individual AIS patients for reperfusion treatment.

Based on those studies, it is still remained unclear whether CTP can be an alternative choice to replace magnetic resonance perfusion (MRP) in AIS patients with extending therapeutic windows. So in this study, the investigators try to determine whether baseline CTP profiles have a comparable ability to MRP in identifying patients who have a robust clinical response after early reperfusion.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The second affiliated hospital of Zhejiang University

Hangzhou, 310000, China

Location status: Recruiting

Location contact

Min Lou, Ph.D

CONTACT

[email protected]

13958007213

About this study

This is a prospective, non-blind, single-center clinical trial to evaluate whether baseline computed tomography perfusion (CTP) profiles have a comparable ability to magnetic resonance perfusion (MRP) in identifying acute ischemia stroke (AIS) patients who have a robust clinical response after early reperfusion.

The study will enroll 1000 patients, and patients will be divided into 2 groups according to the imaging available situation (to see which can provide immediately): CTP scan group and MRP scan group.

Core: CT: cerebral blood flow <30% of that in normal tissue / MR: ADC < 600 ×D10-6 mm2 / s.

Hypoperfusion: CT / MR: time to maximum >6.

For patients accepting CTP or MRP over 4.5 hours after stroke onset, only patients who meet imaging criteria (infarct core volume < 70mL, perfusion lesion volume / infarct core volume >1.2, and absolute mismatch >10 mL) at baseline will receive recombinant tissue plasminogen activator (rt-PA) intravenous thrombolysis. CTP or MRP will be performed at 24 hours after thrombolytic therapy. Modified Rankin score (mRS) will be measured at 3 months after stroke onset.

Study Endpoints: Primary endpoint: mRS 0-2 at 3 months. Secondary endpoints: (1) symptomatic intracranial haemorrhage, (2) reperfusion, (3) recanalization, and (4) infarct growth at 24 hours.

Criteria:

Inclusion criteria

  • Provision of informed consent;
  • Male and female adults aged 18-80 years old;
  • For patients accepting CTP or MRP over 4.5 hours after stroke onset, imaging criteria: infarct core volume <70mL, perfusion leison volume / infarct core volume >1.2, and absolute mismatch >10 mL.

Exclusion criteria

  • Standard contraindications to rt-PA;
  • Contraindication to imaging with contrast agents;
  • Pre-stroke mRS score of ≥2 (indicating previous disability);
  • Participation in any investigational study in the previous 30 days;
  • Any terminal illness such that patient would not be expected to survive more than one-year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Criteria:

Inclusion criteria

  • Provision of informed consent;
  • Male and female adults aged 18-80 years old;
  • For patients accepting CTP or MRP over 4.5 hours after stroke onset, imaging criteria: infarct core volume <70mL, perfusion leison volume / infarct core volume >1.2, and absolute mismatch >10 mL.

Exclusion criteria

  • Standard contraindications to rt-PA;
  • Contraindication to imaging with contrast agents;
  • Pre-stroke mRS score of ≥2 (indicating previous disability);
  • Participation in any investigational study in the previous 30 days;
  • Any terminal illness such that patient would not be expected to survive more than one-year.

Treatment and study plan

inspection mode

Other

different inspection modes:Computed Tomography Perfusion (CTP) or Magnetic Resonance Perfusion (MRP)

Primary outcomes

  1. modified Rankin Scale at 90 days

    Time frame: 90 days

    modified Rankin Scale at 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Min Lou, Ph.D

CONTACT

[email protected]

13958007213

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Comparison Influence to Prognosis of Computed Tomography Perfusion (CTP) and Magnetic Resonance Perfusion (MRP) in Acute Ischemic Stroke (AIS) Patients

Important dates

Study start
2009
Primary completion
2024
Study completion
2026
First posted
Dec 8, 2017
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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