Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients

Cerebrovascular Accident Clinical Trial

Official title:

Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925298
• Other study ID #: ZU-IRB#5335\ 24-6-2018
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2019
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	good neurological Outcome after thrombolysis	Neurological Outcome was assessed by National Institute of Health Stroke Scale (NIHSS) . good outcome (neurological improvement) was defined as 8 points improvement in NIHSS	three months
Primary	poor neurological Outcome after thrombolysis	Neurological Outcome was assessed by the modified Rankin Scale (mRS). The modified Rankin Scale consists of 6 grades, from 0 to 5, with the best score 0 (corresponding to no symptoms) and the worst score 5 (corresponding to severe disability).; Poor outcome was defined as death or disability (mRS scores =2).	three months