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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients

Clinicaltrials.gov identifier NCT03925298

Recruitment Status Completed

First Posted April 24, 2019

Last update posted April 24, 2019

Study Description

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.

  • Condition or Disease:Cerebrovascular Accident
  • Intervention/Treatment:
  • Phase: N/A
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).

Study Design
  • Study Type: Observational [Patient Registry]
  • Actual Enrollment: 81 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients
  • Actual Study Start Date: January 2017
  • Actual Primary Completion Date: January 2019
  • Actual Study Completion Date: March 2019
Outcome Measures
  • Primary Outcome Measures: 1. good neurological Outcome after thrombolysis [ Time Frame: three months ]
    Neurological Outcome was assessed by National Institute of Health Stroke Scale (NIHSS) . good outcome (neurological improvement) was defined as 8 points improvement in NIHSS
  • 2. poor neurological Outcome after thrombolysis [ Time Frame: three months ]
    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).
  • Biospecimen Retention: Samples Without DNA

    Serum troponin I (T-I) was collected at hospital admission at the emergency department, before any treatment. Serum samples from patients were drawn using standard venipuncture techniques. Blood samples were left to clot for 4 hours at room temperature, then centrifuged to obtain the serum which was stored frozen at (-20C). Serum T-I levels were quantified in an enzyme-linked immune-sorbent assay technology (ELISA) following manufacturer's instructions (ALPCO, 26G Keewaydin Drive, Salem NH03079, USA). Upper reference limit for apparently healthy individuals is <0.01μg/l.

Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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.
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 400 mg/dL.

- current use of anticoagulants with an International Normalized Ratio > 1.7 or
prothrombin time>15 sec; platelet count 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

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Zagazig University

More Information
  • Responsible Party: Zagazig University
  • ClinicalTrials.gov Identifier: NCT03925298 History of Changes
  • Other Study ID Numbers: ZU-IRB#5335\ 24-6-2018
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: April 24, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: after publishing the manuscript in the Egyptian journal of neurology. psychiatry and neurosurgery
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP)
  • Time Frame: after publishing the manuscript in the Egyptian journal of neurology. psychiatry and neurosurgery
  • Access Criteria: after publishing the manuscript in the Egyptian journal of neurology. psychiatry and neurosurgery
  • URL: http://ejnpn.springeropen.com
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Zagazig University: acute ischemic stroke
    troponin-I
    intravenous thrombolytic therapy
    outcome
  • Additional relevant MeSH terms: Stroke