Clinical trial NCT03925298: Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients
Official title: Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Accident
Keywords: acute ischemic stroke
troponin-I
outcome
intravenous thrombolytic therapy
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-04-24
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eighty one thrombolysed ischemic stroke patients were enrolled in this study. Participants who did not complete the study (9 Participants were lost during follow up) were eliminated. So the study included seventy two Participants (34 males and 38 females) who fulfilled the inclusion and exclusion criteria.

Brief summary: Elevated level of serum troponin (T-I) has been regarded as a prognostic biomarker of poor outcome in acute ischemic stroke. However, its role in outcome in thrombolysed ischemic stroke patients remains uncertain. The aim of this study was to evaluate the role of T-I as a predictive biomarker of short-term outcome in thrombolysed ischemic stroke participants.

Detailed description: Elevated level of serum troponin (T-I) has been regarded as a prognostic biomarker of poor outcome in acute ischemic stroke. However, its role in outcome in thrombolysed ischemic stroke patients remains uncertain. The aim of this study was to evaluate the role of T-I as a predictive biomarker of short-term outcome in thrombolysed ischemic stroke patients. Methods: This study included 72 acute ischemic stroke participants were treated with intravenous thrombolytic therapy. All participants were subjected to general and neurological evaluation including assessment of stroke severity using National Institute of Health Stroke Scale (NIHSS) at admission and investigations including measurement of serum level of T-I on admission. Outcome was assessed three months after stroke onset using NIHSS and modified Rankin scale (mRS).

Eligibility criteria: Inclusion Criteria:

* Participants were eligible for inclusion in the study if they had evidence suggesting acute ischemic stroke that lasted for ≤ 4.5 hours .
* Those Participants were treated with intravenous thrombolytic therapy ((recombinant tissue plasminogen activator (rt-PA)).

Exclusion Criteria:

* Those who had hemorrhagic stroke
* participants presented with acute myocardial infarction, cerebrovascular stroke in the previous three months.
* serious head trauma in the previous three months.
* urinary tract, lung, or gastrointestinal hemorrhage within the three weeks.
* serious trauma or major surgery within the previous two weeks.
* lumbar or arterial puncture at a non-compressible site within one week.
* those received heparin within 48 hours, resulting in an activated partial thromboplastin time greater than the upper limit of normal.
* systolic pressure \> 185 mmHg or diastolic pressure \> 110 mmHg.
* blood glucose \<50 or \> 400 mg/dL.
* current use of anticoagulants with an International Normalized Ratio \> 1.7 or prothrombin time\>15 sec; platelet count \< 100,000/mm3.
* pregnancy; serious heart, lung, kidney or other organ dysfunction.
* allergy to active ingredients of rt-PA; patients with \> 4.5 hours from the last time known to be asymptomatic.
* those in whom troponin was not measured at admission were excluded from the study

Primary outcomes:
measure: good neurological Outcome after thrombolysis
timeFrame: three months
measure: poor neurological Outcome after thrombolysis
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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