Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients

NCT ID: NCT03925298

Last Updated: 2019-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-03-31

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).

Conditions

Cerebrovascular Accident

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

group 1

participants with elevated serum troponin level (≥0.01μg/L)

No interventions assigned to this group

group 2

those with normal serum troponin level (\<0.01μg/L)

No interventions assigned to this group

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

rania sanad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ZU-IRB#5335\ 24-6-2018

Identifier Type: -

Identifier Source: org_study_id