Cerebrovascular AccidentNCT03925298
Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients
An observational study of Cerebrovascular Accident, run by Zagazig University.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular Accident
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Mar 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)).
Who cannot join
- 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.
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- 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
About this study
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.
Read the 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
- Keywords
- acute ischemic stroke, troponin-I, outcome, intravenous thrombolytic therapy
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | participants with elevated serum troponin level (≥0.01μg/L) | |
| group 2 | those with normal serum troponin level (<0.01μg/L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: three months
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).
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Jan 2017
- Primary completion31 Jan 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, rania sanad, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925298
- Sponsor's protocol ID
- ZU-IRB#5335\ 24-6-2018
- Status last verified
- Apr 2019
- First submitted
- 17 Apr 2019
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after publishing the manuscript in the Egyptian journal of neurology. psychiatry and neurosurgery
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients
- ClinicalTrials.gov ID
- NCT03925298
- Acronym / sponsor ID
- ZU-IRB#5335\ 24-6-2018
- Conditions
- Cerebrovascular Accident
- Keywords
- acute ischemic stroke, troponin-I, outcome, intravenous thrombolytic therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –participants with elevated serum troponin level (≥0.01μg/L) |
| group 2 | – | –those with normal serum troponin level (<0.01μg/L) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Individual participant dataSharing planned: Yes. after publishing the manuscript in the Egyptian journal of neurology. psychiatry and neurosurgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident, run by Zagazig University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
good neurological Outcome after thrombolysis (time frame: three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.