Troponin- I Elevation Predicts Outcome After Thrombolysis... | NCT03925298

Studies
Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients

NCT03925298

Sponsor

Zagazig University

Status

Completed

Last Update Posted

Apr 24, 2019Actual

Enrollment

81Actual

Phase

Not provided

Conditions

Cerebrovascular Accident

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Jan 31, 2019Actual

Completion Date

Mar 31, 2019Actual

First Submitted Date

Apr 17, 2019

First Submission Date that Met QC Criteria

Apr 19, 2019

First Posted Date

Apr 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2019

Last Update Posted Date

Apr 24, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

81Actual

Label	Type	Description	Intervention Names
group 1		participants with elevated serum troponin level (≥0.01μg/L)
group 2		those with normal serum troponin level (<0.01μg/L)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

after publishing the manuscript in the Egyptian journal of neurology. psychiatry and neurosurgery

Types

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

ID	Term
D020521	Stroke
D000083242	Ischemic Stroke

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Description

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.