Stroke, AcuteQICSNCT02647957

A Study of the Efficacy of the Code Stroke in Spain

A study testing Code Stroke in people with Stroke, Acute, run by Universidad Miguel Hernandez de Elche.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Code Stroke is a system for the rapid identification, pre-notification and transport of acute ischemic stroke patients. The objective of this study was to define quality indicators and to compare treatment outcomes in hospitals where Code Stroke has been implemented and hospitals without the use of Code Stroke… Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Stroke, Acute
What is being tested?: Code Stroke
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: No sites listed yet
Study dates: Jan 2016to Apr 2016
Phase: Interventional
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 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

acute ischemic stroke in-patients

Who cannot join

Patients who refuse participate

About this study

Official title: Indicators for Quality Assessment of Hospitalized Ischemic Stroke Patients. A Study of the Efficacy of the Code Stroke in Spain

Read the detailed description

In a first step qualitative technique has been conducted to define treatment quality indicators of acute ischemic stroke patients. In a second step a prospective study is conducted to collect data of 240 inpatients from two groups of hospitals. Two hospitals applying Code Stroke (N= 120) and four hospitals non-applying Code Stroke procedure (N=120). A consecutive sampling method will be conducted. Inclusion criteria: acute ischemic stroke patients treated in the hospitals during the field study. The referral to the hospital could be from primary care, Emergency Unit of other hospital. Patients will enroll after inform consent.

A Singer-blind- research method will applied. Quality indicators defined in the first phase will be applied and comparisons will be realized using ANOVA.

Conditions: Stroke, Acute
Being tested: Code Stroke
Keywords: acute ischemic stroke, quality
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.

Code StrokeProcedure or surgery
Apply a protocol called Code Stroke that involves the entire care chain from emergency teams outpatient specialists of Neurology, Internal Medicine, Radiology or Intensitivos Care, among other hospital areas.

Study groups in NCT02647957
Study group	Role	What they receive
Group A	Experimental	Hospital using Code Stroke Receives: Procedure: Code Stroke
Group B	No intervention	Hospital not using Code Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

Recovery rate of the Intravenous trombolysis treatment
Number of patients showing an adequate recovery after Intravenous trombolysis treatment as assessed by the criteria of the Quality Indicator Board of the German Stroke Registers Study Group and the National Sentinel Audit of Stroke.
Measured: 1 month

Secondary outcomes (6)

Patient satisfaction
Patient Satisfaction Scale
Measured: 1 month
Patient engage
Health literacy Scale
Measured: 1 month
response capacity
Response time for the initial evaluation and treatment
Measured: 1 day
Treatment adequacy: Intravenous trombolysis treatment
Intravenous trombolysis treatment applied in eligible ischemic stroke patients
Measured: 1 month
Patient safety. Complications in the recombinant tissue plasminogen activator treatment after tromobysis
Recombinant tissue plasminogen activator complication rates
Measured: 1 month
Mortality rates of the Intravenous trombolysis treatment
Mortality rates of the Intravenous trombolysis treatment when applied in eligible ischemic stroke patients
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Apr 2016

First posted6 Jan 2016 (estimated)
Study startJan 2016
Primary completionMar 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stroke, AcuteStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02647957
Sponsor's protocol ID: 489/2015
Acronym: QICS
Status last verified: May 2016
First submitted: 26 Dec 2015
Last updated: 12 May 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Alvarez Sabin J, Molina C, Abilleira S, Montaner J, Garcia F, Alijotas J. ["Stroke code". Shortening the delay in reperfusion treatment of acute ischemic stroke]. Med Clin (Barc). 1999 Oct 23;113(13):481-3. Spanish.
PubMed 10604170

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke

All Stroke, Acute trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Indicators for Quality Assessment of Hospitalized Ischemic Stroke Patients. A Study of the Efficacy of the Code Stroke in Spain
ClinicalTrials.gov ID: NCT02647957
Acronym / sponsor ID: QICS / 489/2015
Conditions: Stroke, Acute
Keywords: acute ischemic stroke, quality
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Universidad Miguel Hernandez de ElcheUniversity, hospital or other
Collaborators: Hospital Universitario Ramon y Cajal, Hospital Serranía de Ronda, Hospital of Navarra, Hospital Virgen de la Concha, Hospital of Jaen, Hospital General San Jorge
Study start: Jan 2016
Primary completion: Mar 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 6 Jan 2016 (estimated)
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.

Detailed description

A Singer-blind- research method will applied. Quality indicators defined in the first phase will be applied and comparisons will be realized using ANOVA.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Procedure: Code StrokeHospital using Code Stroke
Group B	No intervention	–Hospital not using Code Stroke

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

acute ischemic stroke in-patients

Key exclusion criteria (1 listed)

Patients who refuse participate

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Code StrokeApply a protocol called Code Stroke that involves the entire care chain from emergency teams outpatient specialists of Neurology, Internal Medicine, Radiology or Intensitivos Care, among other hospital areas.	Procedure or surgery	Group A

Primary outcome

Recovery rate of the Intravenous trombolysis treatment
Time frame: 1 month
Number of patients showing an adequate recovery after Intravenous trombolysis treatment as assessed by the criteria of the Quality Indicator Board of the German Stroke Registers Study Group and the National Sentinel Audit of Stroke.

6 secondary outcomes

Patient satisfaction
Time frame: 1 month
Patient engage
Time frame: 1 month
response capacity
Time frame: 1 day
Treatment adequacy: Intravenous trombolysis treatment
Time frame: 1 month
Patient safety. Complications in the recombinant tissue plasminogen activator treatment after tromobysis
Time frame: 1 month
Mortality rates of the Intravenous trombolysis treatment
Time frame: 1 month

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 12 May 2016.
Results publication: PubMed 10604170Alvarez Sabin J, Molina C, Abilleira S, Montaner J, Garcia F, Alijotas J. ["Stroke code". Shortening the delay in reperfusion treatment of acute ischemic stroke]. Med Clin (Barc). 1999 Oct 23;113(13):481-3. Spanish.
Individual participant dataSharing planned: No

Related trials for Stroke, Acute

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke

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?

A study testing Code Stroke in people with Stroke, Acute, run by Universidad Miguel Hernandez de Elche.

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 1 inclusion and 1 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 12 May 2016. 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?

Recovery rate of the Intravenous trombolysis treatment (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02647957, which also lists 1 linked publication.

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 12 May 2016.